View Future GrowthAllogene Therapeutics 과거 순이익 실적과거 기준 점검 0/6Allogene Therapeutics은 연평균 3.7%의 비율로 수입이 증가해 온 반면, Biotechs 산업은 연평균 36.2%의 비율로 증가했습니다. 매출은 연평균 86.9%의 비율로 감소했습니다.핵심 정보3.69%순이익 성장률13.47%주당순이익(EPS) 성장률Biotechs 산업 성장률17.04%매출 성장률-86.88%자기자본이익률-62.31%순이익률n/a최근 순이익 업데이트31 Mar 2026최근 과거 실적 업데이트공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2026 Results on May 13, 2026Allogene Therapeutics, Inc. announced that they will report Q1, 2026 results After-Market on May 13, 2026공시 • Mar 02Allogene Therapeutics, Inc. to Report Q4, 2025 Results on Mar 12, 2026Allogene Therapeutics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 12, 2026공시 • Oct 30Allogene Therapeutics, Inc. to Report Q3, 2025 Results on Nov 06, 2025Allogene Therapeutics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025공시 • Aug 06Allogene Therapeutics, Inc. to Report Q2, 2025 Results on Aug 13, 2025Allogene Therapeutics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2025 Results on May 13, 2025Allogene Therapeutics, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025Reported Earnings • Mar 14Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2024 results: US$1.32 loss per share (improved from US$2.09 loss in FY 2023). Net loss: US$257.6m (loss narrowed 21% from FY 2023). Products in clinical trials Phase I: 1 Phase II: 1 Revenue missed analyst estimates by 36%. Earnings per share (EPS) exceeded analyst estimates by 3.0%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.모든 업데이트 보기Recent updates공시 • May 29Allogene Therapeutics, Inc. Announces Executive and Board Changes, Effective from June 30, 2026Allogene Therapeutics, Inc. announced that Dr. David Chang, M.D., Ph.D., will continue to serve on the Company’s Board of Directors following his transition from President and Chief Executive Officer, effective June 30, 2026. The Company’s Board of Directors unanimously elected Zachary Roberts, M.D., Ph.D., currently Executive Vice President, Research & Development and Chief Medical Officer, to the Board of Directors, effective July 1, 2026. Dr. Roberts is a physician-scientist and biotechnology executive with more than a decade of leadership experience specifically in CAR T development. Since joining Allogene in January 2023, he has led the Company’s research and development organization, helping shape its clinical and scientific strategy during a pivotal period for the field. Under his leadership, Allogene advanced innovative clinical programs designed to expand the reach of allogeneic CAR T into earlier lines of therapy and new disease settings, including the pivotal ALPHA3 trial in first-line LBCL, which recently reported positive interim futility analysis results. Dr. Roberts has also helped advance Allogene’s efforts into solid tumors and autoimmune disease. Prior to joining Allogene, Dr. Roberts held leadership roles at Instil Bio and Kite Pharma, where he contributed to the development of pioneering CAR T therapies that helped establish the field.공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2026 Results on May 13, 2026Allogene Therapeutics, Inc. announced that they will report Q1, 2026 results After-Market on May 13, 2026공시 • Apr 23Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and AustraliaAllogene Therapeutics, Inc. had regulatory authorities in South Korea and Australia clear the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. The Company recently announced findings from a planned interim futility analysis of the ALPHA3 trial from the first 24 patients enrolled. In this analysis, cema-cel demonstrated a 58.3% (7/12) minimal residual disease (MRD) clearance versus 16.7% (2/12) in the standard-of-care (SOC) observation arm in the 1L consolidation setting. Cema-cel was generally well-tolerated, with no serious treatment-related adverse events and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). There were no hospitalizations for treatment-related adverse events, suggesting consolidation of MRD+ remission with cema-cel may be suitable for a fully outpatient regimen. The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028. Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan. Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom.공시 • Apr 21Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026.공시 • Apr 17Allogene Therapeutics, Inc. Announces Pre-Clinical Data For ALLO-329 Dual-Targeted CD19/CD70 Allogeneic CAR T For Autoimmune DiseasesAllogene Therapeutics, Inc. announced the publication of pre-clinical data for ALLO-329 in Nature Communications. ALLO-329 is an investigational allogeneic CAR T product developed specifically for autoimmune diseases. The publication details the observed precision of ALLO-329 in targeting both CD19+ B cells and CD70+ activated T cells, which are implicated in a range of autoimmune diseases. These findings demonstrate a novel approach to enhance allogeneic CAR T cell activity and persistence in these settings, with a goal of reducing or eliminating significant cytotoxic lymphodepletion. Pre-clinical data show that allogeneic CD19 CAR T cells engineered with an anti-rejection CD70 CAR retain robust anti-CD19 activity, avoid rejection and promote CAR T cell expansion. This dual-targeting approach was also observed to improve therapeutic efficacy in tumor models of antigen loss and achieve suppression of antibody titers in an autoimmune disease model. Integrating both CARs into a single, off-the-shelf allogeneic product has the potential to offer a scalable, consistent manufacturing solution with the ability to expand clinical impact across hematologic malignancies and autoimmune diseases characterized by CD19 and CD70 expression. These findings further validate the potential of the Company’s clinically proven Dagger technology, designed to enhance CAR T cell expansion and persistence. In ALLO-329 for autoimmune disease, this approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion. The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating multiple dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. Competing CAR-T programs in autoimmune disease are evaluating autologous doses 5-10x higher, while other allogeneic approaches use cell doses up to approximately 50x higher than those in the RESOLUTION trial. Initial data from the first dosing cohort are expected in June 2026 and are expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes. Assuming continued enrollment and follow-up, Allogene anticipates providing an additional clinical update later this year. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. In April 2025, the U.S. Food and Drug Administration granted three Fast Track Designations (FTD) to ALLO-329 for the treatment of adult patients with lupus, myositis, and scleroderma. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology.New Risk • Apr 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$195m net loss in 3 years). Significant insider selling over the past 3 months (US$534k sold).공시 • Apr 16Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million.Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 87,500,000 Price\Range: $2 Discount Per Security: $0.12New Risk • Apr 14New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$198m net loss in 3 years). Significant insider selling over the past 3 months (US$534k sold).Price Target Changed • Apr 14Price target increased by 7.8% to US$8.05Up from US$7.47, the current price target is an average from 12 analysts. New target price is 253% above last closing price of US$2.28. Stock is up 56% over the past year. The company is forecast to post a net loss per share of US$0.78 next year compared to a net loss per share of US$0.87 last year.공시 • Apr 14+ 1 more updateNatera, Inc. Highlights Allogene Therapeutic's Positive Interim Futility Analysis From Allogene Therapeutics MRD-Guided Alpha3 Trial In Large B-Cell LymphomaNatera, Inc. highlighted Allogene Therapeutics’ interim futility analysis from its registrational ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel), an investigational allogeneic anti-CD19 CAR T therapy, in first-line consolidation large B-cell lymphoma (LBCL). The ALPHA3 trial is enrolling patients with LBCL who test positive for molecular residual disease (MRD) following first-line therapy. These patients are then randomized either to cema-cel, an investigational allogeneic anti-CD19 CAR T therapy developed by Allogene, or observation. The interim analysis showed that 58.3% of MRD-positive patients treated with cema-cel achieved MRD clearance. In addition, at the Day-45 MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm, suggesting molecular disease progression due to lack of intervention. These findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD. While standard first-line chemoimmunotherapy (e.g., R-CHOP) is effective for most patients in achieving remission, approximately 30% will experience relapse. MRD assessment can identify such relapse before it shows up on imaging. ALPHA3 is the first MRD-guided randomized controlled trial in LBCL. The study is designed to assess whether treatment with an allogenic CAR T product can eliminate residual disease and potentially prevent recurrence. The study identifies high-risk patients using Natera’s CLARITYTM MRD assay, which leverages Natera’s patented phased variant MRD technology. The interim analysis evaluated MRD clearance following treatment at a protocol-defined data cutoff. This represents another critical application for Natera’s MRD technology, providing a meaningful interim endpoint for assessing drug efficacy. Allogene will host a conference call and webcast at 5:30 a.m. PT /8:30 a.m. ET to discuss the interim futility analysis. The webcast will be made available under the Investors tab in the News and Events section.Seeking Alpha • Apr 13Allogene: Early ALPHA3 Data Suggests Potential Paradigm Shift For Cema-Cel In LBCLSummary Allogene Therapeutics is positioned for a paradigm shift in CAR T therapy with cema-cel, targeting earlier, scalable intervention in high-risk LBCL. ALPHA3 interim data showed 58.3% MRD negativity for cema-cel versus 16.7% for observation, with a notably clean safety profile and outpatient feasibility. ALLO's sub-$500M enterprise value suggests the market is only partially pricing in the platform's potential, despite a sharp post-data rally. I maintain a long-term buy rating, expecting future EFS readouts to confirm Cema-Cel's best-in-class potential, though near-term volatility is likely. Read the full article on Seeking Alpha분석 기사 • Apr 10Will Allogene Therapeutics (NASDAQ:ALLO) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. By way of example, Allogene...새로운 내러티브 • Apr 02MRD Guided Cell Therapy And Autoimmune Focus Will Transform Long Term OpportunityCatalysts About Allogene Therapeutics Allogene Therapeutics develops off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?새로운 내러티브 • Mar 19Off The Shelf CAR T Therapies Will Reshape Lymphoma And Autoimmune Treatment TrajectoriesCatalysts About Allogene Therapeutics Allogene Therapeutics develops off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?Recent Insider Transactions Derivative • Mar 17Co-Founder notifies of intention to sell stockDavid Chang intends to sell 48k shares in the next 90 days after lodging an Intent To Sell Form on the 16th of March. If the sale is conducted around the recent share price of US$2.47, it would amount to US$118k. For the year to December 2019, David's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, David's direct individual holding has increased from 5.72m shares to 5.84m. Company insiders have collectively sold US$458k more than they bought, via options and on-market transactions in the last 12 months.새로운 내러티브 • Mar 05Allogeneic CAR T Expectations Will Likely Disappoint As Trial And Cash Runway Risks MountCatalysts About Allogene Therapeutics Allogene Therapeutics is a biotechnology company focused on developing off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?공시 • Mar 02Allogene Therapeutics, Inc. to Report Q4, 2025 Results on Mar 12, 2026Allogene Therapeutics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 12, 2026New Risk • Feb 05New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$379k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$189m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$379k sold).Recent Insider Transactions • Feb 05Co-Founder recently sold US$171k worth of stockOn the 2nd of February, David Chang sold around 95k shares on-market at roughly US$1.80 per share. This transaction amounted to 1.6% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by US$263k.Recent Insider Transactions Derivative • Feb 03Co-Founder notifies of intention to sell stockDavid Chang intends to sell 244k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of February. If the sale is conducted around the recent share price of US$1.80, it would amount to US$439k. For the year to December 2019, David's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, David's direct individual holding has increased from 5.72m shares to 5.73m. Company insiders have collectively sold US$204k more than they bought, via options and on-market transactions in the last 12 months.공시 • Jan 08Allogene Therapeutics, Inc. Positions 2026 as Program-Defining Year for Scalable, Real-World Allogeneic CAR TAllogene Therapeutics, Inc. outlined 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease. After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, Allogene has built an off-the-shelf Car T platform designed to deliver clinical utility, broad patient access, predictable manufacturing, and scalable economics which are core requirements for cell therapy to move beyond a bespoke process toward routine medical practice. A Biologic-Like CAR T Platform Built for Real-World Demand The Company's off-the-shelf approach is purpose-built seeking to deliver the attributes required for sustainable growth and broad patient access, including: Rapid, on-demand availability; Consistent, predictable product performance; Simplified administration compatible with outpatient use and deployment beyond academic centers into community settings; Manufacturing scalability of approximately 30,000 - 60,000+ doses annually; Efficient cost-of-goods profile (< $10K - 20K/dose). Together, these attributes will position Allogene's platform to support broad deployment across hematologic malignancies, autoimmune disease, and solid tumors - enabling CAR T therapy to reach patients earlier, more reliably, and in care settings where most patients are treated. Allogene's lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL). The trial plans to test up to four cell dose levels from a starting cell dose of 20 million CAR T cells in two parallel cohorts (one with a low intensity lymphodepletion and one with no lymphodepletion). Expected to be included in the initial data release are early clinical outcome and supporting translational data covering disease-related biomarkers, CAR T expansion, and immune reconstitution from the first dose level (20 million CAR T cells) cohorts.New Risk • Dec 04New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$190m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).Major Estimate Revision • Nov 13Consensus EPS estimates upgraded to US$0.96 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$0.976 to -US$0.96 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 9.7% next year. Consensus price target of US$7.56 unchanged from last update. Share price rose 11% to US$1.23 over the past week.Price Target Changed • Nov 10Price target decreased by 9.0% to US$7.15Down from US$7.85, the current price target is an average from 11 analysts. New target price is 506% above last closing price of US$1.18. Stock is down 62% over the past year. The company is forecast to post a net loss per share of US$0.97 next year compared to a net loss per share of US$1.32 last year.공시 • Nov 07Allogene Therapeutics Announces Update on Clinical Trials ProgressAllogene Therapeutics, Inc. provided corporate updates. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings. Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL: The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026. The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID: The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population. With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data. ALLO-316: TRAVERSE Trial in RCC: ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO Annual Meeting demonstrated early signs of efficacy and tolerability.공시 • Oct 30Allogene Therapeutics, Inc. to Report Q3, 2025 Results on Nov 06, 2025Allogene Therapeutics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025New Risk • Oct 10New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$203m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).Major Estimate Revision • Aug 21Consensus EPS estimates upgraded to US$0.97 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.03 to -US$0.971 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$7.85 to US$7.56. Share price rose 4.7% to US$1.12 over the past week.공시 • Aug 14Allogene Therapeutics, Inc. Provides Corporate Updates on Key Clinical Trials and Strategic DevelopmentsAllogene Therapeutics, Inc. announced provided corporate updates. Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL- The Company has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. The selection of FC as the lymphodepletion regimen in the ALPHA3 trial reflects strategic advantages supported by preliminary safety and biomarker data. Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile when cema-cel is administered following standard FC. The regimen also offers operational benefits, including ease of administration and the potential for broader adoption within community cancer centers, and is enthusiastically supported by study investigators. In contrast to the relapsed/refractory setting, where a higher disease burden may necessitate more intensive lymphodepletion, standard FC may be sufficient to support the eradication of microscopic disease in earlier lines of treatment. The next milestone will be the futility analysis comparing MRD conversion between the two arms and is expected to occur 1H 2026. The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions. ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID- The Phase 1 RESOLUTION basket trial in rheumatology launched in Second Quarter 2025 and represents a significant step in evaluating CAR T therapy across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product designed to target both CD19+ B cells and CD70+ activated T cells, which are key drivers of autoimmune disease. It leverages CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion to facilitate broader CAR T adoption in autoimmune indications. ALLO-316: TRAVERSE Trial in RCC- ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has been completed in the Phase 1b cohort, which evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC. The Company presented updated Phase 1b cohort data in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and has since met with the FDA to align on the design of a pivotal trial, laying the groundwork for potential partnership discussions to advance the program.공시 • Aug 06Allogene Therapeutics, Inc. to Report Q2, 2025 Results on Aug 13, 2025Allogene Therapeutics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025공시 • Aug 01Allogene Therapeutics Moves Forward with Standard Fludarabine and Cyclophosphamide (Fc) Lymphodepletion Regimen in the Alpha3 Trial for Cemacabtagene Ansegedleucel (Cel) in First-Cel) in First-Cell Consolidation for Large B-Cell LymphomaAllogene Therapeutics, Inc. announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL). This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA). The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. The ability to administer cema-cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review, ultimately transforming care for patients." The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene's clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647. Instead, the Company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger®? Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion.분석 기사 • Jun 12Shareholders May Find It Hard To Justify Increasing Allogene Therapeutics, Inc.'s (NASDAQ:ALLO) CEO Compensation For NowKey Insights Allogene Therapeutics to hold its Annual General Meeting on 18th of June Salary of US$724.0k is part of...Recent Insider Transactions Derivative • Jun 11Independent Director notifies of intention to sell stockDeborah Messemer intends to sell 37k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of June. If the sale is conducted around the recent share price of US$1.42, it would amount to US$52k. Since June 2024, Deborah's direct individual holding has decreased from 166.77k shares to 82.84k. Company insiders have collectively sold US$357k more than they bought, via options and on-market transactions in the last 12 months.Major Estimate Revision • Jun 04Consensus revenue estimates increase by 67%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$10.0k to US$10.0k. EPS estimate unchanged at -US$1.05. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$8.20 unchanged from last update. Share price rose 13% to US$1.29 over the past week.공시 • Jun 02Allogene Therapeutics, Inc. Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma At ASCOAllogene Therapeutics, Inc. presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell Carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled patients with advanced or metastatic renal cell RCC. Leveraging the proprietary Dagger®? technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.공시 • May 23Allogene Therapeutics, Inc. Announces Asco 2025 Abstract Publication Featuring Oral Presentation of Allo-316 in Kidney Cancer and Alpha3 Tip Poster for Cema-CelAllogene Therapeutics, Inc. announced the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in Chicago, Illinois. An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy. Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center; Session Title: Oral Abstract Session - Genitourinary Cancer - Kidney and Bladder; Abstract: #4508; Location: Hall D2; Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CT; Presentation Time: 12:21 PM-12:33 PM CT; ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene Ansegedleucel (CEma-cel) in patients with large B- cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolid for the treatment of LBCL launched in June 2024. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food & Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy ("RMAT") designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of Phase 1 data from clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration agrees with clinical or regulatory plans or the import of clinical results, which could cause future delays to clinical trials or require additional clinical trials; may encounter difficult enrolling patients in the company's clinical trials; may encounter difficult enrollment in patients in the company's clinical trial; and may encounter difficult enrolling patients In the first line (1L) in patients in the second half of the second half of the year.Major Estimate Revision • May 20Consensus revenue estimates decrease by 61%, EPS upgradedThe consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$10.0k to US$10.0k. EPS estimate increased from -US$1.21 to -US$1.03 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$9.18 to US$8.20. Share price rose 2.7% to US$1.16 over the past week.Price Target Changed • May 15Price target decreased by 11% to US$8.20Down from US$9.18, the current price target is an average from 10 analysts. New target price is 652% above last closing price of US$1.09. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$1.03 next year compared to a net loss per share of US$1.32 last year.공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2025 Results on May 13, 2025Allogene Therapeutics, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025공시 • May 01Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2025Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2025.공시 • Apr 23Allogene Therapeutics, Inc. to Present Updated Allo-316 Clinical Results in Kidney Cancer in Oral Presentation and Alpha3 Trial-In-Progress Poster for Cema-Cel At the 2025 American Society of Clinical Oncology (Asco) Annual MeetingAllogene Therapeutics, Inc. announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL). ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center Session Title: Oral Abstract Session - Genitourinary Cancer - Kidney and BladderAbstract: #4508. Presentation Date and Time: Sunday, June 1, 9:45AM - 12:45PM CT.ALPHA3: A pivotal phase 2 study of first-line (1 LBCL) consolidation with cemacabtagene Ansegedleucel (CEma-cel) in patients (pts) with large B- cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy. Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson cancer Center Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic LeukemiaAbstract: TPS7085. Poster Board: #267a Location: Hall A Poster Display Date and Time: Sunday, September 1, 9:00AM - 12:00PM CT.공시 • Apr 08Allogene Therapeutics, Inc. Receives Three Fast Track Designations from the U.S. Food and Drug AdministrationAllogene Therapeutics, Inc. announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immunemediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc). Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression.분석 기사 • Apr 02Here's Why We're Watching Allogene Therapeutics' (NASDAQ:ALLO) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...Recent Insider Transactions • Mar 20Co-Founder recently sold US$91k worth of stockOn the 14th of March, David Chang sold around 47k shares on-market at roughly US$1.96 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by US$169k.Major Estimate Revision • Mar 20Consensus revenue estimates decrease by 48%, EPS upgradedThe consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$30.0k to US$10.0k. EPS estimate increased from -US$1.36 to -US$1.19 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$9.23 to US$8.75. Share price fell 18% to US$1.69 over the past week.Recent Insider Transactions Derivative • Mar 16Co-Founder notifies of intention to sell stockDavid Chang intends to sell 47k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of March. If the sale is conducted around the recent share price of US$1.96, it would amount to US$91k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, David's direct individual holding has increased from 5.23m shares to 8.23m. Company insiders have collectively sold US$267k more than they bought, via options and on-market transactions in the last 12 months.Reported Earnings • Mar 14Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2024 results: US$1.32 loss per share (improved from US$2.09 loss in FY 2023). Net loss: US$257.6m (loss narrowed 21% from FY 2023). Products in clinical trials Phase I: 1 Phase II: 1 Revenue missed analyst estimates by 36%. Earnings per share (EPS) exceeded analyst estimates by 3.0%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.공시 • Mar 03Allogene Therapeutics, Inc. to Report Q4, 2024 Results on Mar 13, 2025Allogene Therapeutics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 13, 2025Seeking Alpha • Feb 25Allogene Therapeutics: Disrupting CAR-T With A Scalable ModelSummary Allogene Therapeutics appears undervalued despite market skepticism, with a robust cash runway and potential breakthroughs in allogeneic CAR-T therapies. The company's lead asset, cema-cel, aims to shift CAR-T therapy to early intervention, potentially expanding its market and redefining treatment standards. ALLO-329 targets autoimmune diseases, positioning Allogene in a new market with significant unmet needs and less competition compared to oncology. Key risks include the efficacy and durability of allogeneic CAR-T therapies and manufacturing consistency, but early data and strategic positioning offer compelling upside potential. Read the full article on Seeking Alpha공시 • Feb 15Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 Alpha/Alpha2 Trials of the Allogeneic Car T Cemacabtagene Ansegedleucel/Refractory Large B-Cell Lymphoma in the Journal of Clinical OncologyAllogene Therapeutics, Inc. announced the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology. These results represent the largest dataset of LBCL patients treated with an allogeneic CAR T product and, with a minimum of two years of follow-up, the longest follow-up to date. As of the data cutoff date (September 26, 2024), 87 heavily pretreated patients with R/R non-Hodgkin lymphoma (NHL) were treated in theALPHA2 studies between May 2019 and September 2022. In total, 33 CD19 CAR T-naive patients with R/R LBCL received cema-cel/ALLO-501 manufactured with the process selected for use in pivotal studies and were the focus of this publication. Overall Response Rate (ORR) and Complete Response (CR) Rate: ORR and CR rates in the ALPHA/ALPHA2 trials were consistent with those observed with approved autologous CD19 CAR T cell products for patients with R/R L BCL after two or more lines of systemic therapy. All treatment regimens studied demonstrated clinical benefit. The selected Phase 2 regimen (fludarabine/cyclophosphamide lymphodepletion with 90 mg of ALLO-647 (FCA90) followed by a single dose of CAR+ cells) yielded the highest ORR and CR of 67% and 58%, respectively. Durability of Response (DOR): Patients who achieved a CR had excellent outcomes with a median DOR, PFS (progression free survival) and OS of 23.1 months, 24 months, and not reached, respectively. For patients receiving the CR, median DOR, PFS(progression free survival) andOS of 23.1 months,24 months, and not reached, both patients receiving the CR in patients with low Disease Burden.Recent Insider Transactions • Feb 07Co-Founder recently sold US$77k worth of stockOn the 3rd of February, David Chang sold around 46k shares on-market at roughly US$1.68 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was David's only on-market trade for the last 12 months.Recent Insider Transactions Derivative • Feb 04Co-Founder notifies of intention to sell stockDavid Chang intends to sell 46k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of February. If the sale is conducted around the recent share price of US$1.68, it would amount to US$77k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, David's direct individual holding has increased from 5.23m shares to 8.28m. Company insiders have collectively sold US$114k more than they bought, via options and on-market transactions in the last 12 months.공시 • Jan 29Allogene Therapeutics, Inc. Announces Executive ChangesAllogene Therapeutics, Inc. announced that Benjamin M. Beneski has been promoted to Senior Vice President and Chief Technical Officer (CTO). Mr. Beneski succeeds Tim Moore, who will be stepping down at the end of February after two years with the Company. Mr. Moore’s impactful career spans nearly a decade of collaboration with the broader team, during which he made significant contributions to Allogene and the field of cell and gene therapy. As CTO, Mr. Beneski will oversee Allogene’s technical operations, leveraging his extensive expertise in biologics manufacturing, process development, and operational leadership to carry on the work of Mr. Moore and further advance the company’s groundbreaking allogeneic cell therapy programs. Mr. Beneski joined Allogene in 2019 as Executive Director and Plant Manager, leading the design, construction, and startup of Cell Forge 1, the company’s state-of-the-art manufacturing facility. Over the years, he has held increasingly senior roles, including Vice President of Manufacturing and Vice President of Product Development and Manufacturing. In these roles, he led the development of next-generation platforms, successfully managed internal and external manufacturing networks, and drove key initiatives supporting IND submissions and commercial readiness. Mr. Beneski’s career spans over two decades in biologics manufacturing and technical operations, including leadership roles at Vir Biotechnology and Amgen. He holds a Master’s in Business Administration from Northeastern University and a Bachelor of Engineering in Chemical Engineering from Stevens Institute of Technology.공시 • Jan 28Allogene Therapeutics, Inc. Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune DiseasesAllogene Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product. The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone which is used by rheumatologists, and another that eliminates lymphodepletion entirely. The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. ALLO-329 represents a next-generation approach to autoimmune therapy, featuring a dual-targeting design against CD19+ B-cells and CD70+ activated T-cells. This innovative strategy is designed to deliver superior therapeutic benefit by addressing both B-cell and T-cell dysfunction, which drive immune dysregulation in autoimmune diseases. The incorporation of Allogene’s proprietary Dagger® technology further empowers ALLO-329 to resist immune rejection, potentially reducing or eliminating the need for lymphodepletion before cell infusion. If successful, this CAR T advancement could significantly simplify treatment protocols, meet the potential scale required to treat autoimmune disease with the capacity to manufacture upwards of 60,000 doses per year, and expand access to transformative CAR T therapy across a wide range of autoimmune disease indications.New Risk • Jan 24New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$88k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$43k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$333m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Significant insider selling over the past 3 months (US$88k sold).공시 • Dec 12Allogene Therapeutics, Inc. Acknowledges the Passing of Founding Board Member David BondermanAllogene Therapeutics, Inc. acknowledged the passing of founding board member, David Bonderman. David died at the age of 82, surrounded by his family. A steadfast advocate for CAR T-cell therapy, David’s contributions to Allogene are immeasurable. He served on Allogene’s Board of Directors since its founding in 2018, taking on the role of Lead Independent Director. In this capacity, he championed innovation, provided trusted mentorship, and served as a constant source of inspiration to all who worked alongside him.Seeking Alpha • Dec 10Allogene Therapeutics: Showing Promise Despite Some Shaky SafetySummary Allogene is among the pioneers in non-self engineered cell therapy. They have demonstrated encouraging early results in lymphoma, moving aggressively into a pivotal trial in the first-line setting. Their pivotal phase 2 trial ALPHA3 has the potential to change how large B-cell lymphoma is managed, but we won't have these results until 2026. Other projects, like their CD70-directed therapy, look promising but have concerning safety signals, and they're also a long way from approval. Read the full article on Seeking Alpha분석 기사 • Nov 22Is Allogene Therapeutics (NASDAQ:ALLO) In A Good Position To Invest In Growth?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • Nov 21Allogene Therapeutics Presents Preclinical Data for ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Disease at the American College of Rheumatology (ACR) ConvergenceAllogene Therapeutics, Inc. announced preclinical data for ALLO-329, an investigational allogeneic CD19/CD70 dual CAR T cell therapy being evaluated as a treatment for autoimmune diseases. The data, presented at the American College of Rheumatology (ACR) Convergence 2024, demonstrate the potential of ALLO-329 to specifically address key challenges associated with current autologous CAR T cell therapies in development for patients with autoimmune disease and highlights the promise of an allogeneic CAR T to reset the immune system.ALLO-329 is the first CAR T designed to target both CD19+ B-cells and CD70+ activated T cells. Targeting of B cells has been shown to induce durable, treatment-free remissions in patients with certain autoimmune diseases. CD70 is expressed in activated T cells, which have been implicated in immune responses, including in autoimmunity. Simultaneous elimination of CD70+ T cells may enhance the therapeutic benefit and expand the list of addressable indications.CD70+ activated T cells also include alloreactive T-cells – the patient’s cells that would attack and reject an allogeneic CAR-T. ALLO-329 is designed to effectively eliminate alloreactive T-cells and render ALLO-329 resistant to rejection. Incorporation of Dagger technology into ALLO-329 is intended to reduce or eliminate lymphodepletion prior to cell infusion. Key findings from the preclinical evaluation of ALLO-329 include: High CAR expression and cytotoxic activity: ALLO-329 produced through site-specific integration of a dual CAR construct into the TRAC locus demonstrated robust CAR expression and specific cytotoxic activity against both CD19+ B cells and CD70+ T cells in vitro and in vivo. Resistance to rejection: In mixed lymphocyte reaction (MLR) assays, ALLO-329 successfully eliminated CD70+ alloreactive T cells, demonstrating resistance to rejection and enhanced persistence compared to CD19 CAR T cells. B cell depletion and antibody reduction: ALLO-329 effectively eradicated B cells derived from healthy donors and patients with systemic lupus erythematosus (SLE) in vitro and in vivo, leading to a reduction in IgG and IgM production. Potential to eliminate lymphodepletion: In humanized pre-clinical models, ALLO-329 demonstrated engraftment, B cell depletion, and expansion even without lymphodepletion. Manufacturability: CRISPR-mediated, T-cell receptor alpha (TRAC) site-specific transgene integration leads to a highly consistent, dual CAR T-expressing product. Based on these promising preclinical results, the Company plans to file an investigational new drug (IND) application with the FDA in the first quarter of 2025 and expects to have proof-of-concept by year-end 2025. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Daggertechnology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.Major Estimate Revision • Nov 14Consensus revenue estimates decrease by 96%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$870.0k to US$30.0k. EPS estimate increased from -US$1.39 to -US$1.35 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target broadly unchanged at US$9.08. Share price fell 23% to US$2.46 over the past week.공시 • Nov 10Allogene Therapeutics, Inc. Reports Unaudited Impairment Charges for the Third Quarter Ended September 30, 2024Allogene Therapeutics, Inc. reported unaudited Impairment charges for the third quarter ended September 30, 2024. For the period, the company reported impairment of long-lived assets of $10,728,000.Reported Earnings • Nov 08Third quarter 2024 earnings released: US$0.32 loss per share (vs US$0.37 loss in 3Q 2023)Third quarter 2024 results: US$0.32 loss per share. Net loss: US$66.3m (loss widened 8.1% from 3Q 2023). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.공시 • Nov 08Allogene Therapeutics, Inc. Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCSAllogene Therapeutics, Inc. will concurrently present new data from the Phase 1 TRAVERSE trial in an oral presentation at the 2024 International Kidney Cancer Symposium (IKCS) and a poster session at The Society for Immunotherapy of Cancer's (SITC) Annual Meeting. The trial evaluates ALLO-316, the Company’s first AlloCAR T product candidate for the potential treatment of solid tumors. The ongoing Phase 1 TRAVERSE trial is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed following treatment with an immune checkpoint inhibitor and VEGF-targeting therapy. These presentations highlight compelling evidence of CAR T activity and anti-tumor efficacy in 26 patients with RCC tumors known to be CD70 positive who were evaluable for efficacy outcomes. As of the October 14, 2024 data cutoff, 39 patients had been enrolled in the ongoing Phase 1 trial, of which 26 were confirmed to have CD70 positive RCC and were evaluable for efficacy outcomes. The median time from enrollment to the start of therapy was five days. Data from dose escalation cohorts and ongoing Phase 1b expansion cohort are included in the presentations. The Phase 1b expansion cohort is evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC500 (fludarabine (30 mg/m/day) and cyclophosphamide (500 mg/m/d) for 3 days) lymphodepletion regimen. The Phase 1b expansion cohort is expected to ultimately include approximately 20 patients. Additional data from the Phase 1b expansion cohort is expected to be announced in mid-2025.Following a single infusion of ALLO-316 in heavily pretreated patients, the trial demonstrated best Overall Response Rate (ORR) of 50% and Confirmed Response Rate of 33% in those patients with CD70 Tumor Proportion Score (TPS) of =50% who received DL2. Patients with a TPS of =50% comprise the majority of patients with advanced or metastatic RCC. Of those with a TPS =50, 76% (16/21) experienced a reduction in tumor burden. Two of six (33%) patients with high TPS who received the Phase 1b expansion regimen showed durable responses ongoing at =4 months. The most common all-grade adverse events were cytokine release syndrome (CRS) (with only one grade =3), fatigue (59%), neutropenia (56%), decreased white blood cell count (54%), anemia (51%) and nausea (51%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was minimal at 8% and no graft-versus-host disease (GvHD) occurred. TEAE included all AEs that started from the first dose date of study drug in each treatment period up to start of another treatment period, death, or the date prior to initiation of another anti-cancer agent, whichever occurred first. IEC-HS includes the preferred terms IEC-HS, HLH, Hemophagocytic lymphohistiocytosis, and atypical HLH. Two patients developed an inflammatory syndrome prior to the existence of IEC-HS as a term in MedDRA, which has been updated as of September 2023. Infection events (62%) were primarily low grade; the most common was viral infections (33%) with cytomegalovirus infection and COVID-19 (any grade, 18% and 15%; Grade =3, 0% and 5%, respectively). Neurotoxicity includes system organ class of nerve system disorders and psychiatric disorders with onset date up to Study Day 30 post ALLO-316 infusion.Two DLT events of autoimmune hepatitis and cardiogenic shock were reported. Each event occurred in 2 separate participants who received FCA (FC300 plus ALLO-647) lymphodepletion and DL2 of ALLO-316. Three Grade 5 treatment-related adverse events were reported: 1) cardiogenic shock, which was one of the 2 DLT events; 2) sepsis from multi-drug resistant Klebsiella pneumoniae in a participant who received DL4 of ALLO-316. This participant had a prior episode of muscle abscess and bacteremia from the same multi-drug resistant Klebsiella and was receiving anakinra and dexamethasone for hyperinflammation; 3) failure to thrive in a participant 16 months after treatment with ALLO-316. This subject had tumor response of stable disease (SD) at month 12 and no interval scans to evaluate disease status prior to death.공시 • Oct 30+ 1 more updateAllogene Therapeutics, Inc. to Report Q3, 2024 Results on Nov 07, 2024Allogene Therapeutics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024Recent Insider Transactions Derivative • Oct 23Executive VP & CFO notifies of intention to sell stockGeoffrey Parker intends to sell 36k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of October. If the sale is conducted around the recent share price of US$2.84, it would amount to US$104k. Since March 2024, Geoffrey's direct individual holding has increased from 190.00 shares to 345.02k. Company insiders have collectively sold US$25k more than they bought, via options and on-market transactions in the last 12 months.Seeking Alpha • Aug 27Allogene Therapeutics: Cema-Cel Promising Among Innovative CAR T-Cell TherapiesSummary Allogene Therapeutics is a clinical-stage biotech developing allogeneic CAR T therapies for cancer and autoimmune diseases, with a focus on Cema-cel for LBCL. ALLO's advanced gene-editing platforms, like TALEN and CRISPR/Cas9, engineer donor-derived T cells to overcome autologous therapy limitations, enhancing treatment safety and effectiveness. Cema-cel, the company’s flagship therapy, is in a pivotal Phase 2 trial (ALPHA3) for large B-cell lymphoma, with potential regulatory submission by 2027. Despite a promising pipeline, ALLO faces cash runway concerns, making it a suitable DCA “buy” for investors aware of clinical trial risks. ALLO's valuation is attractive, with a low P/B multiple and sufficient liquidity to fund operations until the ALPHA3 trial's primary data readout in 2026. Read the full article on Seeking AlphaRecent Insider Transactions Derivative • Aug 23Senior VP notifies of intention to sell stockEarl Douglas intends to sell 28k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of August. If the sale is conducted around the recent share price of US$2.79, it would amount to US$79k. Since March 2024, Earl has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$25k more than they bought, via options and on-market transactions in the last 12 months.Major Estimate Revision • Aug 14Consensus revenue estimates decrease by 58%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$2.09m to US$870.0k. EPS estimate increased from -US$1.53 to -US$1.43 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$11.24 to US$9.28. Share price fell 8.9% to US$2.25 over the past week.Price Target Changed • Aug 08Price target decreased by 17% to US$9.62Down from US$11.66, the current price target is an average from 13 analysts. New target price is 308% above last closing price of US$2.36. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$1.41 next year compared to a net loss per share of US$2.09 last year.공시 • Jul 31Allogene Therapeutics, Inc. to Report Q2, 2024 Results on Aug 07, 2024Allogene Therapeutics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 07, 2024공시 • Jul 01Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)Allogene Therapeutics Inc. announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah Cannon Research Institute (SCRI); Astera Cancer Care (ACC), a multi-specialty community oncology practice and part of the OneOncology network; and Norton Cancer Institute, are open for enrollment in the pivotal Phase 2 ALPHA3 trial. The ALPHA3 trial is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) consolidation treatment regimen for newly diagnosed and treated large B-cell lymphoma (LBCL) patients who remain positive for minimal residual disease (MRD). Detection of MRD will be done using the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. When given as a “7th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates for patients with LBCL who are likely to relapse. RMCC is the largest multidisciplinary practice in Colorado with 19 locations across the state dedicated solely to providing care for patients with cancer and diseases of the blood. RMCC is a part of SCRI, a combination of two nationally recognized oncology research institutes – US Oncology and SCRI. This combination creates a leading oncology research organization participating in community-based clinical trials. Patients undergoing treatment for newly diagnosed LBCL throughout the RMCC network will be considered for enrollment in ALPHA3. ACC is an independent and physician-owned multi-specialty community oncology practice serving more than 22,000 new patients annually in Central New Jersey. The practice is part of the OneOncology platform which is a partnership of over 20 independent community oncology practices nationally. Astera’s specialists practice at 13 distinct locations in Middlesex, Somerset, Bergen, Hudson, Hunterdon, Mercer and Monmouth counties in New Jersey and Langhorne, Pennsylvania and have a robust clinical trial platform for cancer therapy with one of the only community-based clinical trial programs in CAR T cell therapies in the nation. Patients undergoing treatment for newly diagnosed LBCL throughout the ACC network will be considered for enrollment in ALPHA3. With more than 21 locations serving Louisville, Kentucky and Southern Indiana, Norton Cancer Institute (NCI) treats more than 4,000 newly diagnosed cancer patients each year. NCI’s network of multidisciplinary clinics offers patients the latest treatments and access to more than 100 clinical trials.공시 • Jun 20Allogene Therapeutics Inc. Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel as Part of First Line Treatment for Patients with Large B-Cell LymphomaAllogene Therapeutics Inc. and Foresight Diagnostics (Foresight) announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy. The ALPHA3 trial will screen patients who are likely to relapse after 1L treatment for enrollment in the trial by using the Foresight CLARITY Investigational Use Only (IUO) MRD test, powered by PhasED-Seq, which recently received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). In June 2022, the U.S. Food & Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in third line (3L) r/r LBCL. The ALPHA3 trial will be conducted in a wide array of cancer treatment centers, including community cancer centers where most earlier line patients seek care. This randomized study will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). Efficacy analyses are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis in 2H 2026 with a potential biologics license application (BLA) submission targeted for 2027.공시 • Jun 13Allogene Therapeutics, Inc. Announces Executive ChangesOn June 5, 2024, the Board of Directors of Allogene Therapeutics, Inc. appointed Annie Yoshiyama, the Company’s current Senior Vice President and Corporate Controller, as the Company’s principal accounting officer, effective immediately, replacing Geoffrey Parker in such capacity. Mr. Parker continues to serve as the Company’s Chief Financial Officer and principal financial officer. Prior to joining the Company in April 2024, Ms. Yoshiyama, age 41, served as Vice President, Finance & Controller at AN2 Therapeutics, Inc. from September 2023 to March 2024; Senior Vice President Finance and Chief Accounting Officer, Vice President Finance and Chief Accounting Officer, Executive Director Finance, Senior Director Finance, Director SEC Reporting and Technical Accounting, and Associate Director SEC Reporting and Technical Accounting at Tricida, Inc. from June 2018 to March 2023; Senior Financial Reporting and Technical Accounting Manager at Dolby Laboratories from September 2008 to June 2018; and started her career in audit at PricewaterhouseCoopers LLP from September 2005 to August 2007. Ms. Yoshiyama earned her Bachelor of Science and Master of Accounting degrees from the University of Southern California and is a licensed certified public accountant.Seeking Alpha • Jun 12Allogene: Two End Of 2024 Data Readouts With Improved Allogeneic CAR-T ProductsSummary Allogene Therapeutics, Inc. initiation of phase 2 ALPHA3 study, using cema-cel for the treatment of patients with 1st-line large B-cell lymphoma, expected in mid-2024 with two data analysis in 2026. Results from phase 2 ALPHA2 trial, using cema-cel for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia, expected by end of 2024. Results from phase 1 TRAVERSE trial, using ALLO-316 for the treatment of CD70 positive clear cell renal cell carcinoma patients, expected by the end of 2024. Company gained rights from Servier to expand use of cema-cel for r/r CLL and 1st-line LBCL in European and U.K. territories; New potential to tap into >$9.5 billion market opportunity if approval is achieved for these indications. Read the full article on Seeking Alpha분석 기사 • May 30We Discuss Why Allogene Therapeutics, Inc.'s (NASDAQ:ALLO) CEO Compensation May Be Closely ReviewedKey Insights Allogene Therapeutics to hold its Annual General Meeting on 5th of June Total pay for CEO David Chang...Major Estimate Revision • May 20Consensus revenue estimates increase by 2,115%The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$40.0k to US$950.0k. Forecast losses expected to reduce from -US$1.68 to -US$1.61 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$11.66 to US$11.34. Share price fell 4.5% to US$2.77 over the past week.공시 • May 15Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $110.000002 million.Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $110.000002 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 36,896,551 Price\Range: $2.9 Discount Per Security: $0.116 Security Name: Common Stock Security Type: Common Stock Securities Offered: 1,034,484 Price\Range: $2.9 Discount Per Security: $0 Transaction Features: Reserved Share OfferingReported Earnings • May 14First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2024 results: US$0.38 loss per share (improved from US$0.68 loss in 1Q 2023). Net loss: US$65.0m (loss narrowed 34% from 1Q 2023). Revenue exceeded analyst estimates by 111%. Earnings per share (EPS) also surpassed analyst estimates by 6.9%. Revenue is forecast to grow 69% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 54% per year, which means it is performing significantly worse than earnings.공시 • May 08Allogene Therapeutics, Inc. to Report Q1, 2024 Results on May 13, 2024Allogene Therapeutics, Inc. announced that they will report Q1, 2024 results After-Market on May 13, 2024공시 • Apr 28Allogene Therapeutics Receives Grant from the California Institute for Regenerative Medicine to Advance Development of an Allogeneic CAR T in Renal Cell CarcinomaAllogene Therapeutics, Inc. announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an AlloCAR T™ investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC). The grant will support the ongoing Phase 1 TRAVERSE trial which assesses safety, tolerability and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite standard therapy. Initial data from the TRAVERSE trial, presented at AACR 2023, showed promising response rates and early anti-tumor activity with deepening responses over time in participants with a marked unmet medical need. In the TRAVERSE trial, ALLO-316 has demonstrated the potency of the Dagger® technology, which selectively eliminates CD70 positive, alloreactive host immune cells, thus delaying or preventing premature rejection of AlloCAR T cells by the patient’s immune system. ALLO-316 has shown marked expansion and persistence both in preclinical experiments and in clinical trial patients, even when combined with comparatively less-intense lymphodepletion regimens. The intent of this grant will be to facilitate completion of the Phase 1 portion of the trial, including expansion of clinical sites to increase access for diverse patient populations. Additionally, the grant will support translational and clinical analyses to inform a recommended Phase 2 regimen. Details on a potentially cornerstone safety algorithm discovered during the initial portion of the Phase 1 TRAVERSE trial, which may facilitate expanded use of CAR Ts in solid tumors, is planned for a publication in second quarter 2024. A more comprehensive data update from the ongoing trial is planned for later in 2024.Seeking Alpha • Apr 01Allogene Therapeutics: 2024 Platform Vision Sings Mid-Term UpsideSummary Allogene Therapeutics has announced changes to its pipeline that extend its financial runway into 2026. The new ALPHA3 clinical trial for Allogene's Cema-Cel cancer treatment is set to begin in mid-2024, and if successful, investors could see significant returns on their investment. The company's Q42023 report evidenced its financial distress. However, the 2024 platform vision, in my opinion, will have a positive impact on its profitability in the midterm. Given the lack of short-term revenue catalysts, with clinical trials expected to yield results by the end of 2024, investors will be required to be patient, while experiencing high volatility and potential share dilutions this year. Read the full article on Seeking AlphaMajor Estimate Revision • Mar 21Consensus revenue estimates decrease by 43%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$70.0k to US$40.0k. EPS estimate increased from -US$1.75 to -US$1.69 per share. Biotechs industry in the US expected to see average net income decline 8.2% next year. Consensus price target broadly unchanged at US$11.66. Share price fell 9.2% to US$4.43 over the past week.Recent Insider Transactions Derivative • Mar 17Co-Founder notifies of intention to sell stockDavid Chang intends to sell 53k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of March. If the sale is conducted around the recent share price of US$4.33, it would amount to US$231k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, David's direct individual holding has increased from 5.14m shares to 7.43m. Company insiders have collectively sold US$42k more than they bought, via options and on-market transactions in the last 12 months.Reported Earnings • Mar 15Full year 2023 earnings: EPS and revenues miss analyst expectationsFull year 2023 results: US$2.09 loss per share (improved from US$2.32 loss in FY 2022). Net loss: US$327.3m (loss narrowed 1.6% from FY 2022). Revenue missed analyst estimates by 29%. Earnings per share (EPS) also missed analyst estimates by 4.0%. Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 50% per year, which means it is performing significantly worse than earnings.공시 • Mar 06Allogene Therapeutics, Inc. to Report Q4, 2023 Results on Mar 14, 2024Allogene Therapeutics, Inc. announced that they will report Q4, 2023 results After-Market on Mar 14, 2024분석 기사 • Mar 01We Think Allogene Therapeutics (NASDAQ:ALLO) Needs To Drive Business Growth CarefullyThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...Recent Insider Transactions Derivative • Jan 24Insider notifies of intention to sell stockZachary Roberts intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of January. If the sale is conducted around the recent share price of US$3.17, it would amount to US$78k. Since March 2023, Zachary has owned 251.91k shares directly. There has only been one transaction (US$43k sale) from insiders over the last 12 months.공시 • Jan 05Allogene Therapeutics Announces 2024 Platform Vision to Redefine the Future of Car T Led by ALPHA3Allogene Therapeutics, Inc. announced its 2024 Platform Vision that redefines the future of CAR T by leveraging the unique attributes of allogeneic CAR T products. The Foundation: Pivotal ALPHA3 1L Consolidation Trial in Large B Cell Lymphoma (LBCL): In a commanding pivot for the CD19 program, the Company will focus development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A) as part of the first line (1L) treatment plan for newly diagnosed and treated LBCL patients who are likely to relapse and need further therapy. The design of the ALPHA3 1L consolidation trial builds upon the results demonstrated in the Phase 1 ALPHA2 trial and leverages an investigational cutting-edge diagnostic test developed by Foresight Diagnostics to identify patients who have minimal residual disease (MRD) at the completion of 1L chemoimmunotherapy for treatment with cema-cel. Although 1L R-CHOP is curative for many with LBCL, approximately 30% of patients who initially respond will relapsei. The standard of care after 1L treatment has been simply to “watch and wait” for the disease to relapse. ALPHA3 takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. ALPHA3 builds on the growing understanding that administration of CAR T therapies to patients with low disease burden improves both safety and efficacy outcomes. Cema-cel’s Phase 1 safety profile, with low rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), already permits its use in the outpatient setting in relapsed/refractory (r/r) patients and may further improve in patients with no radiological evidence of disease. Start-up activities for the ALPHA3 trial have been initiated. The study will randomize approximately 230 patients who are MRD positive at the end of 1L therapy to either consolidation with cema-cel or the current standard of care (observation). The design, with a primary endpoint of event free survival (EFS), will initially include two lymphodepletion arms (one with standard fludarabine and cyclophosphamide plus ALLO-647 and one without ALLO-647). The outcome of this pivotal trial could allow cema-cel to be embedded in the 1L setting to boost cure rates, potentially rendering later-line treatment obsolete, and making cema-cel available in community cancer centers where most earlier line patients seek care. As a result of this differentiated vision for cema-cel which competitively places its use ahead of other CAR T therapies, the Company will focus on quickly advancing this market-defining ALPHA3 trial and deprioritize the currently enrolling third line (3L) ALPHA2 and EXPAND trials. The Higher Bar: ALPHA2 Cema-Cel Trial in Chronic Lymphocytic Leukemia (CLL): There is a growing need for effective treatment in CLL post-Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 inhibitor (BCL2i) therapies. While recent autologous CD19 CAR T data has been a positive step for patients with r/r CLL, these therapies are still not meeting the efficacy bar or expectations set in r/r LBCL. This is likely due in part to T cell dysfunction and high circulating tumor burden in CLL, making the isolation of functional T cells for autologous CAR T manufacturing difficult. There is strong scientific rationale to believe that an AlloCAR T™ product derived from healthy donor cells could raise the bar and potentially create a clinically meaningful advance for these late-stage patients, with a one-time dose and simpler administration and logistics. The new Phase 1 ALPHA2 cohort of 12 patients treated with the investigational product cema-cel provides the opportunity to set a higher bar where patients with CLL are not reliant on their own T cells’ fitness to benefit from the curative potential of CAR T. This study, driven by investigator enthusiasm, will leverage currently active ALPHA2 trial sites in the U.S. which should allow it to advance quickly. It is expected to begin enrolling in first quarter 2024 with initial data projected by YE 2024.Major Estimate Revision • Dec 18Consensus revenue estimates increase by 10%The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$120.0k to US$140.0k. EPS estimate unchanged from -US$2.01 at last update. Biotechs industry in the US expected to see average net income growth of 8.2% next year. Consensus price target of US$13.13 unchanged from last update. Share price rose 21% to US$2.91 over the past week.공시 • Dec 11Allogene Therapeutics, Inc. Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647Allogene Therapeutics, Inc. announced the presentation of data from a comprehensive safety review of patients treated in the Phase 1 ALPHA/ALPHA2 trials with ALLO-501/501A at the 65th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA. The safety review, which encompasses all 87 Phase 1 patients treated in both relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL), demonstrates that investigational ALLO-647 added to standard lymphodepletion can safely provide a window for the expansion and persistence of AlloCAR T cells, and has the potential to induce deep and durable remissions in relapsed and treatment-refractory cancers. The inclusion of its ALLO-647 candidate in the lymphodepletion regimen is designed to selectively prevent host rejection of allogeneic CAR T cell products. As previously presented in the Phase 1 ALPHA/ALPHA2 studies, CAR T cell-naive patients with r/r LBCL were able to obtain a durable response, including a complete remission rate of 42% and a median duration of response of 23.1 months. In the studies, lymphodepletion consisted of three daily doses of fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses prior to ALLO-501/501A infusion. The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy. No unexpected safety concerns were observed. Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs. Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients. Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy. There were no reports of graft-versus-host disease (GvHD) or Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS). In total, 24% of patients experienced low-grade CRS, and there was 1 Grade 3 CRS event. Infection events were primarily low grade and manageable, with the most common being cytomegalovirus reactivation with an any-grade incidence of 25% and a Grade 3 or higher incidence of 9%. Incidence of infections were consistent with that reported for autologous therapy following lymphodepletion (12%-33% of patients). Eight patients experienced fatal adverse events not related to study treatment. The EXPAND trial, currently enrolling in the United States and Europe, is expected to support licensure of ALLO-647, used in conjunction with standard low-dose FC lymphodepletion regimens. The trial will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS). Separately, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) for the investigation of ALLO-647 in adult patients with r/r LBCL based on its potential to enhance standard lymphodepletion. FTD designation is intended to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available. ALLO-647 is investigated as a lymphodepleting agent in combination with flu/cy prior to infusion of allogeneic CD19-directed CAR T cells with genomes edited to knock out CD52. About ALLO-501 and ALLO-501A: ALLO-501 and ALLO-501A are anti-CD19 AlloCAR TTM investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR TTM product, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.Price Target Changed • Dec 08Price target decreased by 8.5% to US$13.13Down from US$14.36, the current price target is an average from 15 analysts. New target price is 432% above last closing price of US$2.47. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$2.00 next year compared to a net loss per share of US$2.32 last year.Major Estimate Revision • Nov 09Consensus revenue estimates increase by 23%The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$100.0k to US$120.0k. Forecast losses expected to reduce from -US$2.24 to -US$2.02 per share. Biotechs industry in the US expected to see average net income growth of 0.9% next year. Consensus price target down from US$16.71 to US$14.36. Share price was steady at US$2.86 over the past week.Price Target Changed • Nov 07Price target decreased by 14% to US$14.36Down from US$16.71, the current price target is an average from 14 analysts. New target price is 354% above last closing price of US$3.16. Stock is down 65% over the past year. The company is forecast to post a net loss per share of US$2.02 next year compared to a net loss per share of US$2.32 last year.공시 • Nov 04+ 1 more updateAllogene Therapeutics, Inc. Presents Preclinical Data on Next Generation Cloak and Dagger Technologies At the Society for Immunotherapy of Cancer Annual MeetingAllogene Therapeutics, Inc. presented data highlighting the Company’s next generation Cloak™ and Dagger™ technologies designed to help enhance engraftment, expansion and the persistence of AlloCAR T cell candidates, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting November 1-5, 2023, in San Diego, CA. The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients. However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient’s immune system. Allogene’s proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens. The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer (NK) cell rejection while preserving CAR T cell function. Data shown previously demonstrated that knockout of RFX5, a transcriptional regulator that controls expression of HLA molecules, enhanced survival of allogeneic CAR T cells in the presence of host T cells and elicited only minor NK cell reactivity, thereby effectively mitigating rejection. This preclinical study evaluated an additional anti-rejection approach to immune evasion by inactivating CD58 and ICAM-1, key components of the immune synapse required for effective recognition and lysis by alloreactive T/NK cells. In the study, the survival of “cloaked” cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells. The knockout of CD58 and ICAM-1 effectively reduced T cell rejection of allogeneic CAR T cells without triggering NK cell rejection or impacting effector function and worked additively with the knockout of RFX5. The Dagger platform technology arms AlloCAR T cells with a CD70 CAR designed to recognize and deplete CD70-positive host immune cells while enabling tumor-targeting anti-CD19 AlloCAR T cells to resist rejection from the host immune cells. This endows the CAR-expressing T cells with dual specificity against tumors that co-express CD19 and CD70, which includes approximately 70% of patients with large B-cell lymphoma (LBCL). As a result, this potential advance provides both a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells as well as insure against CD19 loss-mediated tumor escape, a known mechanism of resistance to CD19 CAR T therapy. The Dagger technology, a feature of ALLO-316 candidate, has clinically demonstrated its unique immunomodulatory effect, contributing to robust AlloCAR T cell expansion and persistence even with relatively lower doses of CAR T cells and lymphodepletion than in other AlloCAR T programs. The ongoing Phase 1 dose escalation TRAVERSE study using investigational ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy.매출 및 비용 세부 내역Allogene Therapeutics가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이NasdaqGS:ALLO 매출, 비용 및 순이익 (USD Millions)날짜매출순이익일반관리비연구개발비31 Mar 260-17456031 Dec 250-19157030 Sep 250-21259030 Jun 250-23761031 Mar 250-25263031 Dec 240-25865030 Sep 240-28367030 Jun 240-27968031 Mar 240-29270031 Dec 230-32772030 Sep 230-34475030 Jun 230-36577031 Mar 230-36178031 Dec 220-34079030 Sep 220-31378030 Jun 220-30878031 Mar 220-30478031 Dec 21114-18274030 Sep 2138-25171030 Jun 2138-23969031 Mar 2138-22966-4231 Dec 200-31665030 Sep 200-243634930 Jun 200-227628931 Mar 200-2076016331 Dec 190-18557030 Sep 190-1545711430 Jun 190-147538531 Mar 190-2405117531 Dec 180-21241152양질의 수익: ALLO 은(는) 현재 수익성이 없습니다.이익 마진 증가: ALLO는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: ALLO는 수익성이 없지만 지난 5년 동안 연평균 3.7%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 ALLO의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: ALLO은 수익성이 없어 지난 해 수익 성장률을 Biotechs 업계(54.5%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: ALLO는 현재 수익성이 없으므로 자본 수익률이 음수(-62.31%)입니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/06/17 10:12종가2026/06/17 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Allogene Therapeutics, Inc.는 31명의 분석가가 다루고 있습니다. 이 중 10명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Jack AllenBairdShanshan XuBerenbergWilliam PickeringBernstein28명의 분석가 더 보기
공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2026 Results on May 13, 2026Allogene Therapeutics, Inc. announced that they will report Q1, 2026 results After-Market on May 13, 2026
공시 • Mar 02Allogene Therapeutics, Inc. to Report Q4, 2025 Results on Mar 12, 2026Allogene Therapeutics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 12, 2026
공시 • Oct 30Allogene Therapeutics, Inc. to Report Q3, 2025 Results on Nov 06, 2025Allogene Therapeutics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025
공시 • Aug 06Allogene Therapeutics, Inc. to Report Q2, 2025 Results on Aug 13, 2025Allogene Therapeutics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025
공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2025 Results on May 13, 2025Allogene Therapeutics, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025
Reported Earnings • Mar 14Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2024 results: US$1.32 loss per share (improved from US$2.09 loss in FY 2023). Net loss: US$257.6m (loss narrowed 21% from FY 2023). Products in clinical trials Phase I: 1 Phase II: 1 Revenue missed analyst estimates by 36%. Earnings per share (EPS) exceeded analyst estimates by 3.0%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.
공시 • May 29Allogene Therapeutics, Inc. Announces Executive and Board Changes, Effective from June 30, 2026Allogene Therapeutics, Inc. announced that Dr. David Chang, M.D., Ph.D., will continue to serve on the Company’s Board of Directors following his transition from President and Chief Executive Officer, effective June 30, 2026. The Company’s Board of Directors unanimously elected Zachary Roberts, M.D., Ph.D., currently Executive Vice President, Research & Development and Chief Medical Officer, to the Board of Directors, effective July 1, 2026. Dr. Roberts is a physician-scientist and biotechnology executive with more than a decade of leadership experience specifically in CAR T development. Since joining Allogene in January 2023, he has led the Company’s research and development organization, helping shape its clinical and scientific strategy during a pivotal period for the field. Under his leadership, Allogene advanced innovative clinical programs designed to expand the reach of allogeneic CAR T into earlier lines of therapy and new disease settings, including the pivotal ALPHA3 trial in first-line LBCL, which recently reported positive interim futility analysis results. Dr. Roberts has also helped advance Allogene’s efforts into solid tumors and autoimmune disease. Prior to joining Allogene, Dr. Roberts held leadership roles at Instil Bio and Kite Pharma, where he contributed to the development of pioneering CAR T therapies that helped establish the field.
공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2026 Results on May 13, 2026Allogene Therapeutics, Inc. announced that they will report Q1, 2026 results After-Market on May 13, 2026
공시 • Apr 23Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and AustraliaAllogene Therapeutics, Inc. had regulatory authorities in South Korea and Australia clear the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. The Company recently announced findings from a planned interim futility analysis of the ALPHA3 trial from the first 24 patients enrolled. In this analysis, cema-cel demonstrated a 58.3% (7/12) minimal residual disease (MRD) clearance versus 16.7% (2/12) in the standard-of-care (SOC) observation arm in the 1L consolidation setting. Cema-cel was generally well-tolerated, with no serious treatment-related adverse events and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). There were no hospitalizations for treatment-related adverse events, suggesting consolidation of MRD+ remission with cema-cel may be suitable for a fully outpatient regimen. The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028. Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan. Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom.
공시 • Apr 21Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026.
공시 • Apr 17Allogene Therapeutics, Inc. Announces Pre-Clinical Data For ALLO-329 Dual-Targeted CD19/CD70 Allogeneic CAR T For Autoimmune DiseasesAllogene Therapeutics, Inc. announced the publication of pre-clinical data for ALLO-329 in Nature Communications. ALLO-329 is an investigational allogeneic CAR T product developed specifically for autoimmune diseases. The publication details the observed precision of ALLO-329 in targeting both CD19+ B cells and CD70+ activated T cells, which are implicated in a range of autoimmune diseases. These findings demonstrate a novel approach to enhance allogeneic CAR T cell activity and persistence in these settings, with a goal of reducing or eliminating significant cytotoxic lymphodepletion. Pre-clinical data show that allogeneic CD19 CAR T cells engineered with an anti-rejection CD70 CAR retain robust anti-CD19 activity, avoid rejection and promote CAR T cell expansion. This dual-targeting approach was also observed to improve therapeutic efficacy in tumor models of antigen loss and achieve suppression of antibody titers in an autoimmune disease model. Integrating both CARs into a single, off-the-shelf allogeneic product has the potential to offer a scalable, consistent manufacturing solution with the ability to expand clinical impact across hematologic malignancies and autoimmune diseases characterized by CD19 and CD70 expression. These findings further validate the potential of the Company’s clinically proven Dagger technology, designed to enhance CAR T cell expansion and persistence. In ALLO-329 for autoimmune disease, this approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion. The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating multiple dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. Competing CAR-T programs in autoimmune disease are evaluating autologous doses 5-10x higher, while other allogeneic approaches use cell doses up to approximately 50x higher than those in the RESOLUTION trial. Initial data from the first dosing cohort are expected in June 2026 and are expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes. Assuming continued enrollment and follow-up, Allogene anticipates providing an additional clinical update later this year. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. In April 2025, the U.S. Food and Drug Administration granted three Fast Track Designations (FTD) to ALLO-329 for the treatment of adult patients with lupus, myositis, and scleroderma. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology.
New Risk • Apr 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$195m net loss in 3 years). Significant insider selling over the past 3 months (US$534k sold).
공시 • Apr 16Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million.Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 87,500,000 Price\Range: $2 Discount Per Security: $0.12
New Risk • Apr 14New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$198m net loss in 3 years). Significant insider selling over the past 3 months (US$534k sold).
Price Target Changed • Apr 14Price target increased by 7.8% to US$8.05Up from US$7.47, the current price target is an average from 12 analysts. New target price is 253% above last closing price of US$2.28. Stock is up 56% over the past year. The company is forecast to post a net loss per share of US$0.78 next year compared to a net loss per share of US$0.87 last year.
공시 • Apr 14+ 1 more updateNatera, Inc. Highlights Allogene Therapeutic's Positive Interim Futility Analysis From Allogene Therapeutics MRD-Guided Alpha3 Trial In Large B-Cell LymphomaNatera, Inc. highlighted Allogene Therapeutics’ interim futility analysis from its registrational ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel), an investigational allogeneic anti-CD19 CAR T therapy, in first-line consolidation large B-cell lymphoma (LBCL). The ALPHA3 trial is enrolling patients with LBCL who test positive for molecular residual disease (MRD) following first-line therapy. These patients are then randomized either to cema-cel, an investigational allogeneic anti-CD19 CAR T therapy developed by Allogene, or observation. The interim analysis showed that 58.3% of MRD-positive patients treated with cema-cel achieved MRD clearance. In addition, at the Day-45 MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm, suggesting molecular disease progression due to lack of intervention. These findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD. While standard first-line chemoimmunotherapy (e.g., R-CHOP) is effective for most patients in achieving remission, approximately 30% will experience relapse. MRD assessment can identify such relapse before it shows up on imaging. ALPHA3 is the first MRD-guided randomized controlled trial in LBCL. The study is designed to assess whether treatment with an allogenic CAR T product can eliminate residual disease and potentially prevent recurrence. The study identifies high-risk patients using Natera’s CLARITYTM MRD assay, which leverages Natera’s patented phased variant MRD technology. The interim analysis evaluated MRD clearance following treatment at a protocol-defined data cutoff. This represents another critical application for Natera’s MRD technology, providing a meaningful interim endpoint for assessing drug efficacy. Allogene will host a conference call and webcast at 5:30 a.m. PT /8:30 a.m. ET to discuss the interim futility analysis. The webcast will be made available under the Investors tab in the News and Events section.
Seeking Alpha • Apr 13Allogene: Early ALPHA3 Data Suggests Potential Paradigm Shift For Cema-Cel In LBCLSummary Allogene Therapeutics is positioned for a paradigm shift in CAR T therapy with cema-cel, targeting earlier, scalable intervention in high-risk LBCL. ALPHA3 interim data showed 58.3% MRD negativity for cema-cel versus 16.7% for observation, with a notably clean safety profile and outpatient feasibility. ALLO's sub-$500M enterprise value suggests the market is only partially pricing in the platform's potential, despite a sharp post-data rally. I maintain a long-term buy rating, expecting future EFS readouts to confirm Cema-Cel's best-in-class potential, though near-term volatility is likely. Read the full article on Seeking Alpha
분석 기사 • Apr 10Will Allogene Therapeutics (NASDAQ:ALLO) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. By way of example, Allogene...
새로운 내러티브 • Apr 02MRD Guided Cell Therapy And Autoimmune Focus Will Transform Long Term OpportunityCatalysts About Allogene Therapeutics Allogene Therapeutics develops off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?
새로운 내러티브 • Mar 19Off The Shelf CAR T Therapies Will Reshape Lymphoma And Autoimmune Treatment TrajectoriesCatalysts About Allogene Therapeutics Allogene Therapeutics develops off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?
Recent Insider Transactions Derivative • Mar 17Co-Founder notifies of intention to sell stockDavid Chang intends to sell 48k shares in the next 90 days after lodging an Intent To Sell Form on the 16th of March. If the sale is conducted around the recent share price of US$2.47, it would amount to US$118k. For the year to December 2019, David's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, David's direct individual holding has increased from 5.72m shares to 5.84m. Company insiders have collectively sold US$458k more than they bought, via options and on-market transactions in the last 12 months.
새로운 내러티브 • Mar 05Allogeneic CAR T Expectations Will Likely Disappoint As Trial And Cash Runway Risks MountCatalysts About Allogene Therapeutics Allogene Therapeutics is a biotechnology company focused on developing off the shelf allogeneic CAR T cell therapies for cancer and autoimmune diseases. What are the underlying business or industry changes driving this perspective?
공시 • Mar 02Allogene Therapeutics, Inc. to Report Q4, 2025 Results on Mar 12, 2026Allogene Therapeutics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 12, 2026
New Risk • Feb 05New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$379k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$189m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$379k sold).
Recent Insider Transactions • Feb 05Co-Founder recently sold US$171k worth of stockOn the 2nd of February, David Chang sold around 95k shares on-market at roughly US$1.80 per share. This transaction amounted to 1.6% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by US$263k.
Recent Insider Transactions Derivative • Feb 03Co-Founder notifies of intention to sell stockDavid Chang intends to sell 244k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of February. If the sale is conducted around the recent share price of US$1.80, it would amount to US$439k. For the year to December 2019, David's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, David's direct individual holding has increased from 5.72m shares to 5.73m. Company insiders have collectively sold US$204k more than they bought, via options and on-market transactions in the last 12 months.
공시 • Jan 08Allogene Therapeutics, Inc. Positions 2026 as Program-Defining Year for Scalable, Real-World Allogeneic CAR TAllogene Therapeutics, Inc. outlined 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease. After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, Allogene has built an off-the-shelf Car T platform designed to deliver clinical utility, broad patient access, predictable manufacturing, and scalable economics which are core requirements for cell therapy to move beyond a bespoke process toward routine medical practice. A Biologic-Like CAR T Platform Built for Real-World Demand The Company's off-the-shelf approach is purpose-built seeking to deliver the attributes required for sustainable growth and broad patient access, including: Rapid, on-demand availability; Consistent, predictable product performance; Simplified administration compatible with outpatient use and deployment beyond academic centers into community settings; Manufacturing scalability of approximately 30,000 - 60,000+ doses annually; Efficient cost-of-goods profile (< $10K - 20K/dose). Together, these attributes will position Allogene's platform to support broad deployment across hematologic malignancies, autoimmune disease, and solid tumors - enabling CAR T therapy to reach patients earlier, more reliably, and in care settings where most patients are treated. Allogene's lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL). The trial plans to test up to four cell dose levels from a starting cell dose of 20 million CAR T cells in two parallel cohorts (one with a low intensity lymphodepletion and one with no lymphodepletion). Expected to be included in the initial data release are early clinical outcome and supporting translational data covering disease-related biomarkers, CAR T expansion, and immune reconstitution from the first dose level (20 million CAR T cells) cohorts.
New Risk • Dec 04New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$190m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).
Major Estimate Revision • Nov 13Consensus EPS estimates upgraded to US$0.96 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$0.976 to -US$0.96 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 9.7% next year. Consensus price target of US$7.56 unchanged from last update. Share price rose 11% to US$1.23 over the past week.
Price Target Changed • Nov 10Price target decreased by 9.0% to US$7.15Down from US$7.85, the current price target is an average from 11 analysts. New target price is 506% above last closing price of US$1.18. Stock is down 62% over the past year. The company is forecast to post a net loss per share of US$0.97 next year compared to a net loss per share of US$1.32 last year.
공시 • Nov 07Allogene Therapeutics Announces Update on Clinical Trials ProgressAllogene Therapeutics, Inc. provided corporate updates. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings. Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL: The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026. The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID: The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population. With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data. ALLO-316: TRAVERSE Trial in RCC: ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO Annual Meeting demonstrated early signs of efficacy and tolerability.
공시 • Oct 30Allogene Therapeutics, Inc. to Report Q3, 2025 Results on Nov 06, 2025Allogene Therapeutics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025
New Risk • Oct 10New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$203m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).
Major Estimate Revision • Aug 21Consensus EPS estimates upgraded to US$0.97 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.03 to -US$0.971 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$7.85 to US$7.56. Share price rose 4.7% to US$1.12 over the past week.
공시 • Aug 14Allogene Therapeutics, Inc. Provides Corporate Updates on Key Clinical Trials and Strategic DevelopmentsAllogene Therapeutics, Inc. announced provided corporate updates. Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL- The Company has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. The selection of FC as the lymphodepletion regimen in the ALPHA3 trial reflects strategic advantages supported by preliminary safety and biomarker data. Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile when cema-cel is administered following standard FC. The regimen also offers operational benefits, including ease of administration and the potential for broader adoption within community cancer centers, and is enthusiastically supported by study investigators. In contrast to the relapsed/refractory setting, where a higher disease burden may necessitate more intensive lymphodepletion, standard FC may be sufficient to support the eradication of microscopic disease in earlier lines of treatment. The next milestone will be the futility analysis comparing MRD conversion between the two arms and is expected to occur 1H 2026. The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions. ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID- The Phase 1 RESOLUTION basket trial in rheumatology launched in Second Quarter 2025 and represents a significant step in evaluating CAR T therapy across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product designed to target both CD19+ B cells and CD70+ activated T cells, which are key drivers of autoimmune disease. It leverages CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion to facilitate broader CAR T adoption in autoimmune indications. ALLO-316: TRAVERSE Trial in RCC- ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has been completed in the Phase 1b cohort, which evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC. The Company presented updated Phase 1b cohort data in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and has since met with the FDA to align on the design of a pivotal trial, laying the groundwork for potential partnership discussions to advance the program.
공시 • Aug 06Allogene Therapeutics, Inc. to Report Q2, 2025 Results on Aug 13, 2025Allogene Therapeutics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025
공시 • Aug 01Allogene Therapeutics Moves Forward with Standard Fludarabine and Cyclophosphamide (Fc) Lymphodepletion Regimen in the Alpha3 Trial for Cemacabtagene Ansegedleucel (Cel) in First-Cel) in First-Cell Consolidation for Large B-Cell LymphomaAllogene Therapeutics, Inc. announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL). This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA). The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. The ability to administer cema-cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review, ultimately transforming care for patients." The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene's clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647. Instead, the Company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger®? Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion.
분석 기사 • Jun 12Shareholders May Find It Hard To Justify Increasing Allogene Therapeutics, Inc.'s (NASDAQ:ALLO) CEO Compensation For NowKey Insights Allogene Therapeutics to hold its Annual General Meeting on 18th of June Salary of US$724.0k is part of...
Recent Insider Transactions Derivative • Jun 11Independent Director notifies of intention to sell stockDeborah Messemer intends to sell 37k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of June. If the sale is conducted around the recent share price of US$1.42, it would amount to US$52k. Since June 2024, Deborah's direct individual holding has decreased from 166.77k shares to 82.84k. Company insiders have collectively sold US$357k more than they bought, via options and on-market transactions in the last 12 months.
Major Estimate Revision • Jun 04Consensus revenue estimates increase by 67%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$10.0k to US$10.0k. EPS estimate unchanged at -US$1.05. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$8.20 unchanged from last update. Share price rose 13% to US$1.29 over the past week.
공시 • Jun 02Allogene Therapeutics, Inc. Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma At ASCOAllogene Therapeutics, Inc. presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell Carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled patients with advanced or metastatic renal cell RCC. Leveraging the proprietary Dagger®? technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.
공시 • May 23Allogene Therapeutics, Inc. Announces Asco 2025 Abstract Publication Featuring Oral Presentation of Allo-316 in Kidney Cancer and Alpha3 Tip Poster for Cema-CelAllogene Therapeutics, Inc. announced the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in Chicago, Illinois. An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy. Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center; Session Title: Oral Abstract Session - Genitourinary Cancer - Kidney and Bladder; Abstract: #4508; Location: Hall D2; Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CT; Presentation Time: 12:21 PM-12:33 PM CT; ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene Ansegedleucel (CEma-cel) in patients with large B- cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolid for the treatment of LBCL launched in June 2024. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food & Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy ("RMAT") designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of Phase 1 data from clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration agrees with clinical or regulatory plans or the import of clinical results, which could cause future delays to clinical trials or require additional clinical trials; may encounter difficult enrolling patients in the company's clinical trials; may encounter difficult enrollment in patients in the company's clinical trial; and may encounter difficult enrolling patients In the first line (1L) in patients in the second half of the second half of the year.
Major Estimate Revision • May 20Consensus revenue estimates decrease by 61%, EPS upgradedThe consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$10.0k to US$10.0k. EPS estimate increased from -US$1.21 to -US$1.03 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$9.18 to US$8.20. Share price rose 2.7% to US$1.16 over the past week.
Price Target Changed • May 15Price target decreased by 11% to US$8.20Down from US$9.18, the current price target is an average from 10 analysts. New target price is 652% above last closing price of US$1.09. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$1.03 next year compared to a net loss per share of US$1.32 last year.
공시 • May 06Allogene Therapeutics, Inc. to Report Q1, 2025 Results on May 13, 2025Allogene Therapeutics, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025
공시 • May 01Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2025Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2025.
공시 • Apr 23Allogene Therapeutics, Inc. to Present Updated Allo-316 Clinical Results in Kidney Cancer in Oral Presentation and Alpha3 Trial-In-Progress Poster for Cema-Cel At the 2025 American Society of Clinical Oncology (Asco) Annual MeetingAllogene Therapeutics, Inc. announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL). ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center Session Title: Oral Abstract Session - Genitourinary Cancer - Kidney and BladderAbstract: #4508. Presentation Date and Time: Sunday, June 1, 9:45AM - 12:45PM CT.ALPHA3: A pivotal phase 2 study of first-line (1 LBCL) consolidation with cemacabtagene Ansegedleucel (CEma-cel) in patients (pts) with large B- cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy. Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson cancer Center Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic LeukemiaAbstract: TPS7085. Poster Board: #267a Location: Hall A Poster Display Date and Time: Sunday, September 1, 9:00AM - 12:00PM CT.
공시 • Apr 08Allogene Therapeutics, Inc. Receives Three Fast Track Designations from the U.S. Food and Drug AdministrationAllogene Therapeutics, Inc. announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immunemediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc). Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression.
분석 기사 • Apr 02Here's Why We're Watching Allogene Therapeutics' (NASDAQ:ALLO) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
Recent Insider Transactions • Mar 20Co-Founder recently sold US$91k worth of stockOn the 14th of March, David Chang sold around 47k shares on-market at roughly US$1.96 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by US$169k.
Major Estimate Revision • Mar 20Consensus revenue estimates decrease by 48%, EPS upgradedThe consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$30.0k to US$10.0k. EPS estimate increased from -US$1.36 to -US$1.19 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$9.23 to US$8.75. Share price fell 18% to US$1.69 over the past week.
Recent Insider Transactions Derivative • Mar 16Co-Founder notifies of intention to sell stockDavid Chang intends to sell 47k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of March. If the sale is conducted around the recent share price of US$1.96, it would amount to US$91k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, David's direct individual holding has increased from 5.23m shares to 8.23m. Company insiders have collectively sold US$267k more than they bought, via options and on-market transactions in the last 12 months.
Reported Earnings • Mar 14Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2024 results: US$1.32 loss per share (improved from US$2.09 loss in FY 2023). Net loss: US$257.6m (loss narrowed 21% from FY 2023). Products in clinical trials Phase I: 1 Phase II: 1 Revenue missed analyst estimates by 36%. Earnings per share (EPS) exceeded analyst estimates by 3.0%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.
공시 • Mar 03Allogene Therapeutics, Inc. to Report Q4, 2024 Results on Mar 13, 2025Allogene Therapeutics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 13, 2025
Seeking Alpha • Feb 25Allogene Therapeutics: Disrupting CAR-T With A Scalable ModelSummary Allogene Therapeutics appears undervalued despite market skepticism, with a robust cash runway and potential breakthroughs in allogeneic CAR-T therapies. The company's lead asset, cema-cel, aims to shift CAR-T therapy to early intervention, potentially expanding its market and redefining treatment standards. ALLO-329 targets autoimmune diseases, positioning Allogene in a new market with significant unmet needs and less competition compared to oncology. Key risks include the efficacy and durability of allogeneic CAR-T therapies and manufacturing consistency, but early data and strategic positioning offer compelling upside potential. Read the full article on Seeking Alpha
공시 • Feb 15Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 Alpha/Alpha2 Trials of the Allogeneic Car T Cemacabtagene Ansegedleucel/Refractory Large B-Cell Lymphoma in the Journal of Clinical OncologyAllogene Therapeutics, Inc. announced the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology. These results represent the largest dataset of LBCL patients treated with an allogeneic CAR T product and, with a minimum of two years of follow-up, the longest follow-up to date. As of the data cutoff date (September 26, 2024), 87 heavily pretreated patients with R/R non-Hodgkin lymphoma (NHL) were treated in theALPHA2 studies between May 2019 and September 2022. In total, 33 CD19 CAR T-naive patients with R/R LBCL received cema-cel/ALLO-501 manufactured with the process selected for use in pivotal studies and were the focus of this publication. Overall Response Rate (ORR) and Complete Response (CR) Rate: ORR and CR rates in the ALPHA/ALPHA2 trials were consistent with those observed with approved autologous CD19 CAR T cell products for patients with R/R L BCL after two or more lines of systemic therapy. All treatment regimens studied demonstrated clinical benefit. The selected Phase 2 regimen (fludarabine/cyclophosphamide lymphodepletion with 90 mg of ALLO-647 (FCA90) followed by a single dose of CAR+ cells) yielded the highest ORR and CR of 67% and 58%, respectively. Durability of Response (DOR): Patients who achieved a CR had excellent outcomes with a median DOR, PFS (progression free survival) and OS of 23.1 months, 24 months, and not reached, respectively. For patients receiving the CR, median DOR, PFS(progression free survival) andOS of 23.1 months,24 months, and not reached, both patients receiving the CR in patients with low Disease Burden.
Recent Insider Transactions • Feb 07Co-Founder recently sold US$77k worth of stockOn the 3rd of February, David Chang sold around 46k shares on-market at roughly US$1.68 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was David's only on-market trade for the last 12 months.
Recent Insider Transactions Derivative • Feb 04Co-Founder notifies of intention to sell stockDavid Chang intends to sell 46k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of February. If the sale is conducted around the recent share price of US$1.68, it would amount to US$77k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, David's direct individual holding has increased from 5.23m shares to 8.28m. Company insiders have collectively sold US$114k more than they bought, via options and on-market transactions in the last 12 months.
공시 • Jan 29Allogene Therapeutics, Inc. Announces Executive ChangesAllogene Therapeutics, Inc. announced that Benjamin M. Beneski has been promoted to Senior Vice President and Chief Technical Officer (CTO). Mr. Beneski succeeds Tim Moore, who will be stepping down at the end of February after two years with the Company. Mr. Moore’s impactful career spans nearly a decade of collaboration with the broader team, during which he made significant contributions to Allogene and the field of cell and gene therapy. As CTO, Mr. Beneski will oversee Allogene’s technical operations, leveraging his extensive expertise in biologics manufacturing, process development, and operational leadership to carry on the work of Mr. Moore and further advance the company’s groundbreaking allogeneic cell therapy programs. Mr. Beneski joined Allogene in 2019 as Executive Director and Plant Manager, leading the design, construction, and startup of Cell Forge 1, the company’s state-of-the-art manufacturing facility. Over the years, he has held increasingly senior roles, including Vice President of Manufacturing and Vice President of Product Development and Manufacturing. In these roles, he led the development of next-generation platforms, successfully managed internal and external manufacturing networks, and drove key initiatives supporting IND submissions and commercial readiness. Mr. Beneski’s career spans over two decades in biologics manufacturing and technical operations, including leadership roles at Vir Biotechnology and Amgen. He holds a Master’s in Business Administration from Northeastern University and a Bachelor of Engineering in Chemical Engineering from Stevens Institute of Technology.
공시 • Jan 28Allogene Therapeutics, Inc. Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune DiseasesAllogene Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product. The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone which is used by rheumatologists, and another that eliminates lymphodepletion entirely. The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. ALLO-329 represents a next-generation approach to autoimmune therapy, featuring a dual-targeting design against CD19+ B-cells and CD70+ activated T-cells. This innovative strategy is designed to deliver superior therapeutic benefit by addressing both B-cell and T-cell dysfunction, which drive immune dysregulation in autoimmune diseases. The incorporation of Allogene’s proprietary Dagger® technology further empowers ALLO-329 to resist immune rejection, potentially reducing or eliminating the need for lymphodepletion before cell infusion. If successful, this CAR T advancement could significantly simplify treatment protocols, meet the potential scale required to treat autoimmune disease with the capacity to manufacture upwards of 60,000 doses per year, and expand access to transformative CAR T therapy across a wide range of autoimmune disease indications.
New Risk • Jan 24New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$88k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$43k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$333m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Significant insider selling over the past 3 months (US$88k sold).
공시 • Dec 12Allogene Therapeutics, Inc. Acknowledges the Passing of Founding Board Member David BondermanAllogene Therapeutics, Inc. acknowledged the passing of founding board member, David Bonderman. David died at the age of 82, surrounded by his family. A steadfast advocate for CAR T-cell therapy, David’s contributions to Allogene are immeasurable. He served on Allogene’s Board of Directors since its founding in 2018, taking on the role of Lead Independent Director. In this capacity, he championed innovation, provided trusted mentorship, and served as a constant source of inspiration to all who worked alongside him.
Seeking Alpha • Dec 10Allogene Therapeutics: Showing Promise Despite Some Shaky SafetySummary Allogene is among the pioneers in non-self engineered cell therapy. They have demonstrated encouraging early results in lymphoma, moving aggressively into a pivotal trial in the first-line setting. Their pivotal phase 2 trial ALPHA3 has the potential to change how large B-cell lymphoma is managed, but we won't have these results until 2026. Other projects, like their CD70-directed therapy, look promising but have concerning safety signals, and they're also a long way from approval. Read the full article on Seeking Alpha
분석 기사 • Nov 22Is Allogene Therapeutics (NASDAQ:ALLO) In A Good Position To Invest In Growth?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • Nov 21Allogene Therapeutics Presents Preclinical Data for ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Disease at the American College of Rheumatology (ACR) ConvergenceAllogene Therapeutics, Inc. announced preclinical data for ALLO-329, an investigational allogeneic CD19/CD70 dual CAR T cell therapy being evaluated as a treatment for autoimmune diseases. The data, presented at the American College of Rheumatology (ACR) Convergence 2024, demonstrate the potential of ALLO-329 to specifically address key challenges associated with current autologous CAR T cell therapies in development for patients with autoimmune disease and highlights the promise of an allogeneic CAR T to reset the immune system.ALLO-329 is the first CAR T designed to target both CD19+ B-cells and CD70+ activated T cells. Targeting of B cells has been shown to induce durable, treatment-free remissions in patients with certain autoimmune diseases. CD70 is expressed in activated T cells, which have been implicated in immune responses, including in autoimmunity. Simultaneous elimination of CD70+ T cells may enhance the therapeutic benefit and expand the list of addressable indications.CD70+ activated T cells also include alloreactive T-cells – the patient’s cells that would attack and reject an allogeneic CAR-T. ALLO-329 is designed to effectively eliminate alloreactive T-cells and render ALLO-329 resistant to rejection. Incorporation of Dagger technology into ALLO-329 is intended to reduce or eliminate lymphodepletion prior to cell infusion. Key findings from the preclinical evaluation of ALLO-329 include: High CAR expression and cytotoxic activity: ALLO-329 produced through site-specific integration of a dual CAR construct into the TRAC locus demonstrated robust CAR expression and specific cytotoxic activity against both CD19+ B cells and CD70+ T cells in vitro and in vivo. Resistance to rejection: In mixed lymphocyte reaction (MLR) assays, ALLO-329 successfully eliminated CD70+ alloreactive T cells, demonstrating resistance to rejection and enhanced persistence compared to CD19 CAR T cells. B cell depletion and antibody reduction: ALLO-329 effectively eradicated B cells derived from healthy donors and patients with systemic lupus erythematosus (SLE) in vitro and in vivo, leading to a reduction in IgG and IgM production. Potential to eliminate lymphodepletion: In humanized pre-clinical models, ALLO-329 demonstrated engraftment, B cell depletion, and expansion even without lymphodepletion. Manufacturability: CRISPR-mediated, T-cell receptor alpha (TRAC) site-specific transgene integration leads to a highly consistent, dual CAR T-expressing product. Based on these promising preclinical results, the Company plans to file an investigational new drug (IND) application with the FDA in the first quarter of 2025 and expects to have proof-of-concept by year-end 2025. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Daggertechnology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
Major Estimate Revision • Nov 14Consensus revenue estimates decrease by 96%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$870.0k to US$30.0k. EPS estimate increased from -US$1.39 to -US$1.35 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target broadly unchanged at US$9.08. Share price fell 23% to US$2.46 over the past week.
공시 • Nov 10Allogene Therapeutics, Inc. Reports Unaudited Impairment Charges for the Third Quarter Ended September 30, 2024Allogene Therapeutics, Inc. reported unaudited Impairment charges for the third quarter ended September 30, 2024. For the period, the company reported impairment of long-lived assets of $10,728,000.
Reported Earnings • Nov 08Third quarter 2024 earnings released: US$0.32 loss per share (vs US$0.37 loss in 3Q 2023)Third quarter 2024 results: US$0.32 loss per share. Net loss: US$66.3m (loss widened 8.1% from 3Q 2023). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US.
공시 • Nov 08Allogene Therapeutics, Inc. Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCSAllogene Therapeutics, Inc. will concurrently present new data from the Phase 1 TRAVERSE trial in an oral presentation at the 2024 International Kidney Cancer Symposium (IKCS) and a poster session at The Society for Immunotherapy of Cancer's (SITC) Annual Meeting. The trial evaluates ALLO-316, the Company’s first AlloCAR T product candidate for the potential treatment of solid tumors. The ongoing Phase 1 TRAVERSE trial is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed following treatment with an immune checkpoint inhibitor and VEGF-targeting therapy. These presentations highlight compelling evidence of CAR T activity and anti-tumor efficacy in 26 patients with RCC tumors known to be CD70 positive who were evaluable for efficacy outcomes. As of the October 14, 2024 data cutoff, 39 patients had been enrolled in the ongoing Phase 1 trial, of which 26 were confirmed to have CD70 positive RCC and were evaluable for efficacy outcomes. The median time from enrollment to the start of therapy was five days. Data from dose escalation cohorts and ongoing Phase 1b expansion cohort are included in the presentations. The Phase 1b expansion cohort is evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC500 (fludarabine (30 mg/m/day) and cyclophosphamide (500 mg/m/d) for 3 days) lymphodepletion regimen. The Phase 1b expansion cohort is expected to ultimately include approximately 20 patients. Additional data from the Phase 1b expansion cohort is expected to be announced in mid-2025.Following a single infusion of ALLO-316 in heavily pretreated patients, the trial demonstrated best Overall Response Rate (ORR) of 50% and Confirmed Response Rate of 33% in those patients with CD70 Tumor Proportion Score (TPS) of =50% who received DL2. Patients with a TPS of =50% comprise the majority of patients with advanced or metastatic RCC. Of those with a TPS =50, 76% (16/21) experienced a reduction in tumor burden. Two of six (33%) patients with high TPS who received the Phase 1b expansion regimen showed durable responses ongoing at =4 months. The most common all-grade adverse events were cytokine release syndrome (CRS) (with only one grade =3), fatigue (59%), neutropenia (56%), decreased white blood cell count (54%), anemia (51%) and nausea (51%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was minimal at 8% and no graft-versus-host disease (GvHD) occurred. TEAE included all AEs that started from the first dose date of study drug in each treatment period up to start of another treatment period, death, or the date prior to initiation of another anti-cancer agent, whichever occurred first. IEC-HS includes the preferred terms IEC-HS, HLH, Hemophagocytic lymphohistiocytosis, and atypical HLH. Two patients developed an inflammatory syndrome prior to the existence of IEC-HS as a term in MedDRA, which has been updated as of September 2023. Infection events (62%) were primarily low grade; the most common was viral infections (33%) with cytomegalovirus infection and COVID-19 (any grade, 18% and 15%; Grade =3, 0% and 5%, respectively). Neurotoxicity includes system organ class of nerve system disorders and psychiatric disorders with onset date up to Study Day 30 post ALLO-316 infusion.Two DLT events of autoimmune hepatitis and cardiogenic shock were reported. Each event occurred in 2 separate participants who received FCA (FC300 plus ALLO-647) lymphodepletion and DL2 of ALLO-316. Three Grade 5 treatment-related adverse events were reported: 1) cardiogenic shock, which was one of the 2 DLT events; 2) sepsis from multi-drug resistant Klebsiella pneumoniae in a participant who received DL4 of ALLO-316. This participant had a prior episode of muscle abscess and bacteremia from the same multi-drug resistant Klebsiella and was receiving anakinra and dexamethasone for hyperinflammation; 3) failure to thrive in a participant 16 months after treatment with ALLO-316. This subject had tumor response of stable disease (SD) at month 12 and no interval scans to evaluate disease status prior to death.
공시 • Oct 30+ 1 more updateAllogene Therapeutics, Inc. to Report Q3, 2024 Results on Nov 07, 2024Allogene Therapeutics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024
Recent Insider Transactions Derivative • Oct 23Executive VP & CFO notifies of intention to sell stockGeoffrey Parker intends to sell 36k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of October. If the sale is conducted around the recent share price of US$2.84, it would amount to US$104k. Since March 2024, Geoffrey's direct individual holding has increased from 190.00 shares to 345.02k. Company insiders have collectively sold US$25k more than they bought, via options and on-market transactions in the last 12 months.
Seeking Alpha • Aug 27Allogene Therapeutics: Cema-Cel Promising Among Innovative CAR T-Cell TherapiesSummary Allogene Therapeutics is a clinical-stage biotech developing allogeneic CAR T therapies for cancer and autoimmune diseases, with a focus on Cema-cel for LBCL. ALLO's advanced gene-editing platforms, like TALEN and CRISPR/Cas9, engineer donor-derived T cells to overcome autologous therapy limitations, enhancing treatment safety and effectiveness. Cema-cel, the company’s flagship therapy, is in a pivotal Phase 2 trial (ALPHA3) for large B-cell lymphoma, with potential regulatory submission by 2027. Despite a promising pipeline, ALLO faces cash runway concerns, making it a suitable DCA “buy” for investors aware of clinical trial risks. ALLO's valuation is attractive, with a low P/B multiple and sufficient liquidity to fund operations until the ALPHA3 trial's primary data readout in 2026. Read the full article on Seeking Alpha
Recent Insider Transactions Derivative • Aug 23Senior VP notifies of intention to sell stockEarl Douglas intends to sell 28k shares in the next 90 days after lodging an Intent To Sell Form on the 21st of August. If the sale is conducted around the recent share price of US$2.79, it would amount to US$79k. Since March 2024, Earl has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$25k more than they bought, via options and on-market transactions in the last 12 months.
Major Estimate Revision • Aug 14Consensus revenue estimates decrease by 58%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$2.09m to US$870.0k. EPS estimate increased from -US$1.53 to -US$1.43 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$11.24 to US$9.28. Share price fell 8.9% to US$2.25 over the past week.
Price Target Changed • Aug 08Price target decreased by 17% to US$9.62Down from US$11.66, the current price target is an average from 13 analysts. New target price is 308% above last closing price of US$2.36. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$1.41 next year compared to a net loss per share of US$2.09 last year.
공시 • Jul 31Allogene Therapeutics, Inc. to Report Q2, 2024 Results on Aug 07, 2024Allogene Therapeutics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 07, 2024
공시 • Jul 01Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)Allogene Therapeutics Inc. announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah Cannon Research Institute (SCRI); Astera Cancer Care (ACC), a multi-specialty community oncology practice and part of the OneOncology network; and Norton Cancer Institute, are open for enrollment in the pivotal Phase 2 ALPHA3 trial. The ALPHA3 trial is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) consolidation treatment regimen for newly diagnosed and treated large B-cell lymphoma (LBCL) patients who remain positive for minimal residual disease (MRD). Detection of MRD will be done using the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. When given as a “7th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates for patients with LBCL who are likely to relapse. RMCC is the largest multidisciplinary practice in Colorado with 19 locations across the state dedicated solely to providing care for patients with cancer and diseases of the blood. RMCC is a part of SCRI, a combination of two nationally recognized oncology research institutes – US Oncology and SCRI. This combination creates a leading oncology research organization participating in community-based clinical trials. Patients undergoing treatment for newly diagnosed LBCL throughout the RMCC network will be considered for enrollment in ALPHA3. ACC is an independent and physician-owned multi-specialty community oncology practice serving more than 22,000 new patients annually in Central New Jersey. The practice is part of the OneOncology platform which is a partnership of over 20 independent community oncology practices nationally. Astera’s specialists practice at 13 distinct locations in Middlesex, Somerset, Bergen, Hudson, Hunterdon, Mercer and Monmouth counties in New Jersey and Langhorne, Pennsylvania and have a robust clinical trial platform for cancer therapy with one of the only community-based clinical trial programs in CAR T cell therapies in the nation. Patients undergoing treatment for newly diagnosed LBCL throughout the ACC network will be considered for enrollment in ALPHA3. With more than 21 locations serving Louisville, Kentucky and Southern Indiana, Norton Cancer Institute (NCI) treats more than 4,000 newly diagnosed cancer patients each year. NCI’s network of multidisciplinary clinics offers patients the latest treatments and access to more than 100 clinical trials.
공시 • Jun 20Allogene Therapeutics Inc. Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel as Part of First Line Treatment for Patients with Large B-Cell LymphomaAllogene Therapeutics Inc. and Foresight Diagnostics (Foresight) announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy. The ALPHA3 trial will screen patients who are likely to relapse after 1L treatment for enrollment in the trial by using the Foresight CLARITY Investigational Use Only (IUO) MRD test, powered by PhasED-Seq, which recently received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). In June 2022, the U.S. Food & Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in third line (3L) r/r LBCL. The ALPHA3 trial will be conducted in a wide array of cancer treatment centers, including community cancer centers where most earlier line patients seek care. This randomized study will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). Efficacy analyses are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis in 2H 2026 with a potential biologics license application (BLA) submission targeted for 2027.
공시 • Jun 13Allogene Therapeutics, Inc. Announces Executive ChangesOn June 5, 2024, the Board of Directors of Allogene Therapeutics, Inc. appointed Annie Yoshiyama, the Company’s current Senior Vice President and Corporate Controller, as the Company’s principal accounting officer, effective immediately, replacing Geoffrey Parker in such capacity. Mr. Parker continues to serve as the Company’s Chief Financial Officer and principal financial officer. Prior to joining the Company in April 2024, Ms. Yoshiyama, age 41, served as Vice President, Finance & Controller at AN2 Therapeutics, Inc. from September 2023 to March 2024; Senior Vice President Finance and Chief Accounting Officer, Vice President Finance and Chief Accounting Officer, Executive Director Finance, Senior Director Finance, Director SEC Reporting and Technical Accounting, and Associate Director SEC Reporting and Technical Accounting at Tricida, Inc. from June 2018 to March 2023; Senior Financial Reporting and Technical Accounting Manager at Dolby Laboratories from September 2008 to June 2018; and started her career in audit at PricewaterhouseCoopers LLP from September 2005 to August 2007. Ms. Yoshiyama earned her Bachelor of Science and Master of Accounting degrees from the University of Southern California and is a licensed certified public accountant.
Seeking Alpha • Jun 12Allogene: Two End Of 2024 Data Readouts With Improved Allogeneic CAR-T ProductsSummary Allogene Therapeutics, Inc. initiation of phase 2 ALPHA3 study, using cema-cel for the treatment of patients with 1st-line large B-cell lymphoma, expected in mid-2024 with two data analysis in 2026. Results from phase 2 ALPHA2 trial, using cema-cel for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia, expected by end of 2024. Results from phase 1 TRAVERSE trial, using ALLO-316 for the treatment of CD70 positive clear cell renal cell carcinoma patients, expected by the end of 2024. Company gained rights from Servier to expand use of cema-cel for r/r CLL and 1st-line LBCL in European and U.K. territories; New potential to tap into >$9.5 billion market opportunity if approval is achieved for these indications. Read the full article on Seeking Alpha
분석 기사 • May 30We Discuss Why Allogene Therapeutics, Inc.'s (NASDAQ:ALLO) CEO Compensation May Be Closely ReviewedKey Insights Allogene Therapeutics to hold its Annual General Meeting on 5th of June Total pay for CEO David Chang...
Major Estimate Revision • May 20Consensus revenue estimates increase by 2,115%The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$40.0k to US$950.0k. Forecast losses expected to reduce from -US$1.68 to -US$1.61 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$11.66 to US$11.34. Share price fell 4.5% to US$2.77 over the past week.
공시 • May 15Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $110.000002 million.Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $110.000002 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 36,896,551 Price\Range: $2.9 Discount Per Security: $0.116 Security Name: Common Stock Security Type: Common Stock Securities Offered: 1,034,484 Price\Range: $2.9 Discount Per Security: $0 Transaction Features: Reserved Share Offering
Reported Earnings • May 14First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2024 results: US$0.38 loss per share (improved from US$0.68 loss in 1Q 2023). Net loss: US$65.0m (loss narrowed 34% from 1Q 2023). Revenue exceeded analyst estimates by 111%. Earnings per share (EPS) also surpassed analyst estimates by 6.9%. Revenue is forecast to grow 69% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 54% per year, which means it is performing significantly worse than earnings.
공시 • May 08Allogene Therapeutics, Inc. to Report Q1, 2024 Results on May 13, 2024Allogene Therapeutics, Inc. announced that they will report Q1, 2024 results After-Market on May 13, 2024
공시 • Apr 28Allogene Therapeutics Receives Grant from the California Institute for Regenerative Medicine to Advance Development of an Allogeneic CAR T in Renal Cell CarcinomaAllogene Therapeutics, Inc. announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an AlloCAR T™ investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC). The grant will support the ongoing Phase 1 TRAVERSE trial which assesses safety, tolerability and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite standard therapy. Initial data from the TRAVERSE trial, presented at AACR 2023, showed promising response rates and early anti-tumor activity with deepening responses over time in participants with a marked unmet medical need. In the TRAVERSE trial, ALLO-316 has demonstrated the potency of the Dagger® technology, which selectively eliminates CD70 positive, alloreactive host immune cells, thus delaying or preventing premature rejection of AlloCAR T cells by the patient’s immune system. ALLO-316 has shown marked expansion and persistence both in preclinical experiments and in clinical trial patients, even when combined with comparatively less-intense lymphodepletion regimens. The intent of this grant will be to facilitate completion of the Phase 1 portion of the trial, including expansion of clinical sites to increase access for diverse patient populations. Additionally, the grant will support translational and clinical analyses to inform a recommended Phase 2 regimen. Details on a potentially cornerstone safety algorithm discovered during the initial portion of the Phase 1 TRAVERSE trial, which may facilitate expanded use of CAR Ts in solid tumors, is planned for a publication in second quarter 2024. A more comprehensive data update from the ongoing trial is planned for later in 2024.
Seeking Alpha • Apr 01Allogene Therapeutics: 2024 Platform Vision Sings Mid-Term UpsideSummary Allogene Therapeutics has announced changes to its pipeline that extend its financial runway into 2026. The new ALPHA3 clinical trial for Allogene's Cema-Cel cancer treatment is set to begin in mid-2024, and if successful, investors could see significant returns on their investment. The company's Q42023 report evidenced its financial distress. However, the 2024 platform vision, in my opinion, will have a positive impact on its profitability in the midterm. Given the lack of short-term revenue catalysts, with clinical trials expected to yield results by the end of 2024, investors will be required to be patient, while experiencing high volatility and potential share dilutions this year. Read the full article on Seeking Alpha
Major Estimate Revision • Mar 21Consensus revenue estimates decrease by 43%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$70.0k to US$40.0k. EPS estimate increased from -US$1.75 to -US$1.69 per share. Biotechs industry in the US expected to see average net income decline 8.2% next year. Consensus price target broadly unchanged at US$11.66. Share price fell 9.2% to US$4.43 over the past week.
Recent Insider Transactions Derivative • Mar 17Co-Founder notifies of intention to sell stockDavid Chang intends to sell 53k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of March. If the sale is conducted around the recent share price of US$4.33, it would amount to US$231k. For the year to December 2018, David's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, David's direct individual holding has increased from 5.14m shares to 7.43m. Company insiders have collectively sold US$42k more than they bought, via options and on-market transactions in the last 12 months.
Reported Earnings • Mar 15Full year 2023 earnings: EPS and revenues miss analyst expectationsFull year 2023 results: US$2.09 loss per share (improved from US$2.32 loss in FY 2022). Net loss: US$327.3m (loss narrowed 1.6% from FY 2022). Revenue missed analyst estimates by 29%. Earnings per share (EPS) also missed analyst estimates by 4.0%. Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 50% per year, which means it is performing significantly worse than earnings.
공시 • Mar 06Allogene Therapeutics, Inc. to Report Q4, 2023 Results on Mar 14, 2024Allogene Therapeutics, Inc. announced that they will report Q4, 2023 results After-Market on Mar 14, 2024
분석 기사 • Mar 01We Think Allogene Therapeutics (NASDAQ:ALLO) Needs To Drive Business Growth CarefullyThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
Recent Insider Transactions Derivative • Jan 24Insider notifies of intention to sell stockZachary Roberts intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of January. If the sale is conducted around the recent share price of US$3.17, it would amount to US$78k. Since March 2023, Zachary has owned 251.91k shares directly. There has only been one transaction (US$43k sale) from insiders over the last 12 months.
공시 • Jan 05Allogene Therapeutics Announces 2024 Platform Vision to Redefine the Future of Car T Led by ALPHA3Allogene Therapeutics, Inc. announced its 2024 Platform Vision that redefines the future of CAR T by leveraging the unique attributes of allogeneic CAR T products. The Foundation: Pivotal ALPHA3 1L Consolidation Trial in Large B Cell Lymphoma (LBCL): In a commanding pivot for the CD19 program, the Company will focus development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A) as part of the first line (1L) treatment plan for newly diagnosed and treated LBCL patients who are likely to relapse and need further therapy. The design of the ALPHA3 1L consolidation trial builds upon the results demonstrated in the Phase 1 ALPHA2 trial and leverages an investigational cutting-edge diagnostic test developed by Foresight Diagnostics to identify patients who have minimal residual disease (MRD) at the completion of 1L chemoimmunotherapy for treatment with cema-cel. Although 1L R-CHOP is curative for many with LBCL, approximately 30% of patients who initially respond will relapsei. The standard of care after 1L treatment has been simply to “watch and wait” for the disease to relapse. ALPHA3 takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD. ALPHA3 builds on the growing understanding that administration of CAR T therapies to patients with low disease burden improves both safety and efficacy outcomes. Cema-cel’s Phase 1 safety profile, with low rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), already permits its use in the outpatient setting in relapsed/refractory (r/r) patients and may further improve in patients with no radiological evidence of disease. Start-up activities for the ALPHA3 trial have been initiated. The study will randomize approximately 230 patients who are MRD positive at the end of 1L therapy to either consolidation with cema-cel or the current standard of care (observation). The design, with a primary endpoint of event free survival (EFS), will initially include two lymphodepletion arms (one with standard fludarabine and cyclophosphamide plus ALLO-647 and one without ALLO-647). The outcome of this pivotal trial could allow cema-cel to be embedded in the 1L setting to boost cure rates, potentially rendering later-line treatment obsolete, and making cema-cel available in community cancer centers where most earlier line patients seek care. As a result of this differentiated vision for cema-cel which competitively places its use ahead of other CAR T therapies, the Company will focus on quickly advancing this market-defining ALPHA3 trial and deprioritize the currently enrolling third line (3L) ALPHA2 and EXPAND trials. The Higher Bar: ALPHA2 Cema-Cel Trial in Chronic Lymphocytic Leukemia (CLL): There is a growing need for effective treatment in CLL post-Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 inhibitor (BCL2i) therapies. While recent autologous CD19 CAR T data has been a positive step for patients with r/r CLL, these therapies are still not meeting the efficacy bar or expectations set in r/r LBCL. This is likely due in part to T cell dysfunction and high circulating tumor burden in CLL, making the isolation of functional T cells for autologous CAR T manufacturing difficult. There is strong scientific rationale to believe that an AlloCAR T™ product derived from healthy donor cells could raise the bar and potentially create a clinically meaningful advance for these late-stage patients, with a one-time dose and simpler administration and logistics. The new Phase 1 ALPHA2 cohort of 12 patients treated with the investigational product cema-cel provides the opportunity to set a higher bar where patients with CLL are not reliant on their own T cells’ fitness to benefit from the curative potential of CAR T. This study, driven by investigator enthusiasm, will leverage currently active ALPHA2 trial sites in the U.S. which should allow it to advance quickly. It is expected to begin enrolling in first quarter 2024 with initial data projected by YE 2024.
Major Estimate Revision • Dec 18Consensus revenue estimates increase by 10%The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$120.0k to US$140.0k. EPS estimate unchanged from -US$2.01 at last update. Biotechs industry in the US expected to see average net income growth of 8.2% next year. Consensus price target of US$13.13 unchanged from last update. Share price rose 21% to US$2.91 over the past week.
공시 • Dec 11Allogene Therapeutics, Inc. Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647Allogene Therapeutics, Inc. announced the presentation of data from a comprehensive safety review of patients treated in the Phase 1 ALPHA/ALPHA2 trials with ALLO-501/501A at the 65th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA. The safety review, which encompasses all 87 Phase 1 patients treated in both relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL), demonstrates that investigational ALLO-647 added to standard lymphodepletion can safely provide a window for the expansion and persistence of AlloCAR T cells, and has the potential to induce deep and durable remissions in relapsed and treatment-refractory cancers. The inclusion of its ALLO-647 candidate in the lymphodepletion regimen is designed to selectively prevent host rejection of allogeneic CAR T cell products. As previously presented in the Phase 1 ALPHA/ALPHA2 studies, CAR T cell-naive patients with r/r LBCL were able to obtain a durable response, including a complete remission rate of 42% and a median duration of response of 23.1 months. In the studies, lymphodepletion consisted of three daily doses of fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses prior to ALLO-501/501A infusion. The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy. No unexpected safety concerns were observed. Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs. Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients. Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy. There were no reports of graft-versus-host disease (GvHD) or Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS). In total, 24% of patients experienced low-grade CRS, and there was 1 Grade 3 CRS event. Infection events were primarily low grade and manageable, with the most common being cytomegalovirus reactivation with an any-grade incidence of 25% and a Grade 3 or higher incidence of 9%. Incidence of infections were consistent with that reported for autologous therapy following lymphodepletion (12%-33% of patients). Eight patients experienced fatal adverse events not related to study treatment. The EXPAND trial, currently enrolling in the United States and Europe, is expected to support licensure of ALLO-647, used in conjunction with standard low-dose FC lymphodepletion regimens. The trial will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS). Separately, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) for the investigation of ALLO-647 in adult patients with r/r LBCL based on its potential to enhance standard lymphodepletion. FTD designation is intended to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available. ALLO-647 is investigated as a lymphodepleting agent in combination with flu/cy prior to infusion of allogeneic CD19-directed CAR T cells with genomes edited to knock out CD52. About ALLO-501 and ALLO-501A: ALLO-501 and ALLO-501A are anti-CD19 AlloCAR TTM investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR TTM product, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.
Price Target Changed • Dec 08Price target decreased by 8.5% to US$13.13Down from US$14.36, the current price target is an average from 15 analysts. New target price is 432% above last closing price of US$2.47. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$2.00 next year compared to a net loss per share of US$2.32 last year.
Major Estimate Revision • Nov 09Consensus revenue estimates increase by 23%The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$100.0k to US$120.0k. Forecast losses expected to reduce from -US$2.24 to -US$2.02 per share. Biotechs industry in the US expected to see average net income growth of 0.9% next year. Consensus price target down from US$16.71 to US$14.36. Share price was steady at US$2.86 over the past week.
Price Target Changed • Nov 07Price target decreased by 14% to US$14.36Down from US$16.71, the current price target is an average from 14 analysts. New target price is 354% above last closing price of US$3.16. Stock is down 65% over the past year. The company is forecast to post a net loss per share of US$2.02 next year compared to a net loss per share of US$2.32 last year.
공시 • Nov 04+ 1 more updateAllogene Therapeutics, Inc. Presents Preclinical Data on Next Generation Cloak and Dagger Technologies At the Society for Immunotherapy of Cancer Annual MeetingAllogene Therapeutics, Inc. presented data highlighting the Company’s next generation Cloak™ and Dagger™ technologies designed to help enhance engraftment, expansion and the persistence of AlloCAR T cell candidates, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting November 1-5, 2023, in San Diego, CA. The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients. However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient’s immune system. Allogene’s proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens. The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer (NK) cell rejection while preserving CAR T cell function. Data shown previously demonstrated that knockout of RFX5, a transcriptional regulator that controls expression of HLA molecules, enhanced survival of allogeneic CAR T cells in the presence of host T cells and elicited only minor NK cell reactivity, thereby effectively mitigating rejection. This preclinical study evaluated an additional anti-rejection approach to immune evasion by inactivating CD58 and ICAM-1, key components of the immune synapse required for effective recognition and lysis by alloreactive T/NK cells. In the study, the survival of “cloaked” cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells. The knockout of CD58 and ICAM-1 effectively reduced T cell rejection of allogeneic CAR T cells without triggering NK cell rejection or impacting effector function and worked additively with the knockout of RFX5. The Dagger platform technology arms AlloCAR T cells with a CD70 CAR designed to recognize and deplete CD70-positive host immune cells while enabling tumor-targeting anti-CD19 AlloCAR T cells to resist rejection from the host immune cells. This endows the CAR-expressing T cells with dual specificity against tumors that co-express CD19 and CD70, which includes approximately 70% of patients with large B-cell lymphoma (LBCL). As a result, this potential advance provides both a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells as well as insure against CD19 loss-mediated tumor escape, a known mechanism of resistance to CD19 CAR T therapy. The Dagger technology, a feature of ALLO-316 candidate, has clinically demonstrated its unique immunomodulatory effect, contributing to robust AlloCAR T cell expansion and persistence even with relatively lower doses of CAR T cells and lymphodepletion than in other AlloCAR T programs. The ongoing Phase 1 dose escalation TRAVERSE study using investigational ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy.
