Ankündigung • Jan 07
Achilles Therapeutics plc Announces Board Resignations On December 31, 2024, Julie O’Neill, Michael Giordano and Bernhard Ehmer each resigned as a director from the board of directors (the “Board”) of Achilles Therapeutics plc (“Achilles” or the “Company”), effective immediately. Ms. O’Neill had served on the Board since 2021 and was a member of the Audit Committee of the Board. Dr. Giordano had served on the Board since 2018 and was a member of the Remuneration Committee of the Board, Nominating Committee of the Board, and Research & Development Committee of the Board. Dr. Ehmer had served on the Board since 2022 and was a member of the Research & Development Committee of the Board. Ankündigung • Dec 26
AstraZeneca PLC (LSE:AZN) acquired Technology Assets of Achilles Therapeutics plc (NasdaqCM:ACHL) for $12 million. AstraZeneca PLC (LSE:AZN) acquired Technology Assets of Achilles Therapeutics plc (NasdaqCM:ACHL) for $12 million on December 24, 2024. A cash consideration of $12 million will be paid by AstraZeneca PLC. As part of consideration, $12 million is paid towards assets of Technology Assets of Achilles Therapeutics. Under the transaction, Achilles has transfered Proprietary data and samples from TRACERx and Achilles’ Material Acquisition Platform(MAP).
BofA Securities provided strategic financial advise to Achilles Therapeutics plc in the transaction.
AstraZeneca PLC (LSE:AZN) completed the acquisition of Technology Assets of Achilles Therapeutics plc (NasdaqCM:ACHL) on December 24, 2024. Ankündigung • Nov 21
Achilles Therapeutics Receives Approval to Transfer its American Depositary Shares from Nasdaq Global Market to Nasdaq Capital Market Achilles Therapeutics plc announced that on November 15, 2024, the Listing Qualifications department of the Nasdaq Stock Market LLC (‘Nasdaq’) approved the Company's request to transfer the listing of the Company's American Depositary Shares (the ‘ADSs’) from the Nasdaq Global Market to the Nasdaq Capital Market. The transfer is expected to take effect at the opening of business on November 19, 2024. The transfer of the Company's listing to the Nasdaq Capital Market is not expected to have any impact on trading in the Company's ADSs. The Company's ADSs will continue to trade under the symbol ‘ACHL.’ The approval by Nasdaq was conditioned upon the Company meeting the applicable market value requirement of publicly held shares for continued listing and all other applicable requirements for listing on the Nasdaq Capital Market. As previously disclosed, on May 17, 2024, the Company received a letter from Nasdaq indicating that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price of the ADSs had been below US$1.00 per ADS for the previous 30 consecutive business days. The Company was given a period of 180 calendar days to regain compliance with the minimum bid price requirement. In response, the Company submitted an application to transfer the listing of its ADSs from the Nasdaq Global Market to the Nasdaq Capital Market. As a result of the transfer to the Nasdaq Capital Market, the Company will be eligible for an additional 180 calendar days to regain compliance with the requirements set forth in Nasdaq Listing Rule 5450(a)(1) that the bid price of the Company’s shares meet or exceed $1.00 per share for at least ten consecutive business days (the ‘Minimum Bid Price Rule’). The Company intends to continue to actively monitor the minimum bid price requirement and, as appropriate, will consider available options to resolve any deficiencies and regain compliance. New Risk • Sep 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% 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 Risks Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$119m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$29.2m market cap). Price Target Changed • May 17
Price target decreased by 25% to US$4.13 Down from US$5.50, the current price target is an average from 4 analysts. New target price is 351% above last closing price of US$0.92. Stock is down 9.4% over the past year. The company is forecast to post a net loss per share of US$0.98 next year compared to a net loss per share of US$1.74 last year. Board Change • Apr 11
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 6 experienced directors. 1 highly experienced director. CEO & Director Iraj Ali is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Apr 04
Achilles Therapeutics plc Provides Interim Phase I/IIa Update on Clonal Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma Including First Patients Dosed with Enhanced Host Conditioning Achilles Therapeutics plc announced interim Phase I/IIa data on the use of clonal neoantigen reactive T cells (cNeT) from the CHIRON study in advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and the THETIS study in recurrent or metastatic malignant melanoma. The update includes data from 18 patients across CHIRON (n=12) and THETIS (n=6) dosed since the previous interim update in December 2022, with two CHIRON patients and one THETIS patient having received enhanced chemo-conditioning and IL-2 dosing aligned to standard tumor infiltrating lymphocyte (TIL) therapy (enhanced host conditioning) in a new Cohort C. This new Cohort C will allow the impact of enhanced host conditioning on cNeT engraftment and persistence beyond 28 days to be evaluated. All trial participants were late-stage, checkpoint refractory patients with progressive disease at the time of lymphodepletion. The observed tolerability profiles remain favorable and similar to standard TIL therapy. The VELOS™ manufacturing process continued to improve with a median 172 million cNeT dosed across the eighteen patients in the update compared to 18 million cNeT in the December 2022 update, with 10 products over 100 million cNeT and five over one billion cNeT. Summary of new patients treated since the previous update: 18 new patients treated since the last update (12 NSCLC in CHIRON, 6 melanoma in THETIS) with a median of two prior lines of therapy; Data update includes two CHIRON Cohort C (enhanced host conditioning), one THETIS Cohort C and two THETIS Cohort B patients (checkpoint combination); Median cNeT dose of 172 million in the 18 patients reported since the last update with 10 of 18 patients dosed with over 100 million cNeT, including five products over one billion cNeT. Continued favorable tolerability profile for cNeT: Tolerability observations for cNeT compare well with standard TIL therapy; Lymphopenia and neutropenia were the most common adverse events, which are principally associated with the conditioning regimen, and no dose limiting high-grade toxicities were observed. 25% of higher dose (>100M cNeT) patients in CHIRON and THETIS (3 of 12) demonstrated stable disease with some reduction in tumor volume: No new objective responses were observed, which is believed to relate to a lack of cNeT persistence with the previous host-conditioning regimen using lower lymphodepletion and IL-2 compared to standard TIL therapy; Early and significant peaks of cNeT, similar to standard TIL therapy, were observed in the blood of patients receiving reduced intensity conditioning, though with a lack of consistent cNeT persistence beyond 28 days. Enhanced host conditioning cohort opened in CHIRON and THETIS: Enhanced host conditioning protocol Cohort C has been added to CHIRON and THETIS to evaluate an enhanced regimen of increased lymphodepletion intensity and increased IL-2 dosing on cNeT persistence and hence potentially clinical activity; All three patients dosed using the enhanced host conditioning regimen have shown improvement in cNeT engraftment and some tumor reduction in one case; TCR tracking shows more durable cNeT engraftment beyond week six in the first patient treated with enhanced host-conditioning regimen; A further eight patients are currently under observation with products ready for dosing with a cNeT product. VELOS Manufacturing process further enhanced: 172 million median cNeT dose for the last 18 patients in this update compared to a median of 18 million cNeT in the December 2022 update; The last 10 products manufactured have delivered a median cNeT dose of 611 million. New Risk • Feb 29
New minor risk - Share price stability The 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 Risks Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$157m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$64.0m market cap). Price Target Changed • Dec 17
Price target decreased by 19% to US$6.88 Down from US$8.50, the current price target is an average from 4 analysts. New target price is 690% above last closing price of US$0.87. Stock is up 2.4% over the past year. The company is forecast to post a net loss per share of US$1.44 next year compared to a net loss per share of US$1.82 last year. Ankündigung • Sep 24
Achilles Therapeutics Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement Achilles Therapeutics plc disclosed that the Company received notice on September 20, 2023 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the Company’s American Depositary Shares (the “ADS”) on the Nasdaq Global Select Market, as set in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until March 18, 2024 (the “Compliance Deadline”), to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of the Company’s ADSs meet or exceed $1.00 per ADS for at least ten consecutive business days. The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s ADSs, and its ADSs will continue to trade on The Nasdaq Global Select Market under the symbol “ACHL” at this time. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance by the Compliance Deadline, the Company may be afforded an additional 180 calendar day period to regain compliance. Ankündigung • May 11
Achilles Therapeutics plc Announces New Immunogenicity Prediction Application of its AI-Powered PELEUS Platform Uniquely Identifies Most Potent T Cell Antigens Achilles Therapeutics plc announced that the Company’s new AI application, trained with proprietary real-world data, outperformed current AI and non-AI methods for neoantigen immunogenicity prediction in a recent analysis, enabling the identification of the most potent clonal neoantigens for personalized cancer therapies. Further details of this new capability of the Company’s AI-powered PELEUS™ bioinformatics platform are expected to be presented at an upcoming scientific meeting. Of the large numbers of neoantigens that are initially identified in a patient’s tumor, only a fraction will yield T cell responses that can deliver clinical benefit. Achilles has developed an AI tool to enable the prospective identification of the most potent neoantigens. The new PELEUS™ neoantigen immunogenicity ranking module was trained and validated with data from over 10,000 neoantigens from in-silico identification through expansion and characterization of actual T cell clones. With this new tool, the PELEUS™ platform can accurately predict which neoantigens are most likely to generate a potent T cell response, supporting the potential implementation of the platform into the Company’s ongoing TIL-based clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma, and into other modalities including clonal neoantigen cancer vaccines. The analysis conducted by the Bioinformatics & Data Science Team at Achilles demonstrated that the PELEUS™ platform delivered significantly improved ranking performance when compared to currently used state-of-the-art methods as measured by “Receiver Operating Characteristic Area Under the Curve” (ROC AUC). ROC AUC evaluates the performance of a machine learning model to predict neoantigens that are confirmed in vivo. The PELEUS™ AI immunogenicity ranking tool was developed and trained using proprietary real-world data from patient material from Achilles’ Material Acquisition Program (MAP), the ongoing CHIRON trial in patients with advanced NSCLC, and the THETIS trial in patients with recurrent or metastatic melanoma. Current AI methods are trained on publicly available data from sources such as the Immune Epitope Database (IEDB), a freely available resource funded by the National Institute of Allergy and Infection Disease (NIAID). Ankündigung • Dec 01
Achilles Therapeutics plc Updates Interim Results from the Ongoing Phase I/IIa Chiron and Thetis Clinical Trials Achilles Therapeutics plc announced that an abstract highlighting updated interim results from the ongoing Phase I/IIa CHIRON and THETIS clinical trials evaluating clonal neoantigen-reactive T cells (cNeT) has been accepted for a poster presentation at the ESMO Immuno-Oncology Annual Congress (ESMO IO) taking place in Geneva, Switzerland from December 7-9, 2022. cNeT are the active component of the final, precision T cell product which target tumors through recognition of a patient’s clonal neoantigens present on all tumor cells. Data on 14 heavily pre-treated patients (eight patients from CHIRON with advanced NSCLC and six patients from THETIS with recurrent melanoma) that received cNeT as monotherapy and had completed at least one post-treatment scan six weeks following dosing by the abstract cut-off date will be presented. Safety and tolerability observations of cNeT compare favorably to standard tumor infiltrating lymphocytes (TIL) due to less IL-2 related toxicity. Lymphopenia and neutropenia were the most common adverse events, which are principally associated with the conditioning regimen, and no dose limiting high-grade toxicities associated with IL-2 were reported. The best clinical response was a partial response (ongoing at week 33) in a NSCLC patient that showed an investigator-reported 57% total tumor reduction at week 24. Translational science analysis shows that peak expansion of cytokine-secreting cNeT at day 21 was coincident with signs of systemic immune activation including increased serum IL-6. Stable disease was observed in five NSCLC patients through week 12, with two patients remaining stable beyond weeks 15 and 26. Further characterization of cNeT using single cell RNA and TCR-seq suggests that cNeT products are polyclonal, with reactive T cell clusters bearing signatures of T cell proliferation, cytokine secretion, and tissue migration. Price Target Changed • Nov 16
Price target increased to US$12.80 Up from US$11.25, the current price target is an average from 5 analysts. New target price is 640% above last closing price of US$1.73. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$1.70 next year compared to a net loss per share of US$2.13 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. CEO & Director Iraj Ali is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Jul 01
Achilles Therapeutics plc Announces Management Appointments, Effective July 1, 2022 Achilles Therapeutics plc announced the appointment of James Taylor as Chief Business Officer and Cassian Yee, MD to its Scientific Advisory Board, effective July 1, 2022. James brings over 25 years of value-creating deal experience that includes global platform and asset deals for pharmaceutical and biotechnology companies. Most recently, he was Chief Business Officer at Sosei Heptares, where he completed a major collaboration with Neurocrine Biosciences for a Phase II-ready M4 agonist for schizophrenia, and led deals with Genentech, Takeda, AbbVie, GSK, Verily, Aditum and Biohaven Pharmaceuticals. Prior to this, James was a senior director at GSK where he led deals with GlycoVaxyn, Novartis, Pfizer, Biological E and consulted for Galvani Bioelectronics, the GSK/Google joint venture. He has held executive management roles at AstraZeneca, Summit Therapeutics and Cellzome. The Company has also expanded its Scientific Advisory Board with the addition of Cassian Yee, MD. Dr. Yee is a professor in the department of melanoma medical oncology and the department of immunology at The University of Texas MD Anderson Cancer Center, as well as director of the solid tumor cell therapy program at MD Anderson. He is a highly regarded immuno-oncology leader, and notable pioneer in the field of adoptive cellular therapy. Price Target Changed • May 28
Price target decreased to US$14.40 Down from US$16.80, the current price target is an average from 4 analysts. New target price is 463% above last closing price of US$2.56. Stock is down 80% over the past year. The company is forecast to post a net loss per share of US$2.23 next year compared to a net loss per share of US$2.13 last year. Ankündigung • May 27
Achilles Therapeutics plc, Annual General Meeting, Jun 28, 2022 Achilles Therapeutics plc, Annual General Meeting, Jun 28, 2022, at 16:00 Coordinated Universal Time. Location: 245 Hammersmith Road London United Kingdom Agenda: To consider the re-elections of directors; to re-appoint KPMG LLP, an English registered limited liability partnership, as UK statutory auditors of the company, to hold office until the conclusion of the next annual general meeting of shareholders; to authorize the company's audit committee to determine our auditors' remuneration for the fiscal year ending 31 December 2022; to receive the UK statutory annual accounts and reports for the fiscal year ended 31 December 2021 and to note that the directors do not recommend the payment of any dividend for the year ended 31 December 2021;to approve the Directors’ Remuneration Policy set out on pages 15 to 24 of the 2021 Annual Report, which, if approved, will take effect immediately after the conclusion of the AGM on 28 June 2022; and to consider other matters. Ankündigung • May 10
Achilles Therapeutics plc Doses First Patient with Higher-dose cNeT in Phase I/IIa CHIRON Trial in Advanced NSCLC and Initiates Enrollment in Cohort B of the THETIS Trial (cNeT + PD-1 checkpoint inhibitor) in Metastatic Malignant Melanoma Achilles Therapeutics plc announced that the first patient has been dosed with personalized clonal neoantigen-reactive T cells, or cNeT, manufactured with the Company’s higher-dose VELOS™ Process 2 in the ongoing Phase I/IIa CHIRON clinical trial for the treatment of advanced non-small cell lung cancer (NSCLC). Additionally, following a positive review by an Independent Data Safety Monitoring Committee, the Company has initiated enrollment in Cohort B of the THETIS clinical trial to evaluate cNeT in combination with a PD-1 checkpoint inhibitor for the treatment of metastatic malignant melanoma. VELOS is a scalable commercial manufacturing process designed to be closed and automated. The proprietary process uses dendritic cells to deliver a personalized, precision T cell-based therapy that selectively targets multiple clonal neoantigens with improved T cell fitness and reduced need for high-dose IL-2. As original mutations formed early in cancer development, clonal neoantigens are protein markers present on all cancer cells but absent from healthy tissue, making them ideal cancer targets. Ankündigung • May 05
Achilles Therapeutics plc Announces Management Changes Achilles Therapeutics plc announced the appointment of Bernhard Ehmer, MD, to the Board as a Non-Executive Director. Bernhard joins Achilles with a strong track record in international R&D, regulatory and commercial activities. Achilles also announced that Derek DiRocco of RA Capital Management has resigned from the Board of Directors effective May 3, 2022. Board Change • Apr 27
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. CEO & Director Iraj Ali is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Feb 08
Achilles Therapeutics plc Appoints Alena Gros and Ben Creelan to Its Scientific Advisory Board Achilles Therapeutics plc announced the appointment of Alena Gros, Ph.D. and Ben Creelan, M.D. to its Scientific Advisory Board. Dr. Alena Gros is an internationally recognized expert in cancer immunology and immunotherapy, and currently serves as Principal Investigator of the Tumor Immunology and Immunotherapy Group at Vall d’Hebron Institute of Oncology in Barcelona, Spain. Dr. Ben Creelan is a leading medical oncologist and clinical and translational research physician in the thoracic oncology department at Moffitt Cancer Center, Tampa, FL. Ankündigung • Jul 02
Achilles Therapeutics Enrolls First Us Patient in Ongoing Phase I/Iia Study in Advanced Non-Small Cell Lung Cancer Achilles Therapeutics plc announced that the first patient in the United States (US) has been enrolled in the Company’s ongoing Phase I/IIa CHIRON clinical trial. CHIRON is an open-label, multi-center Phase I/IIa trial evaluating the safety, tolerability, and activity of clonal neoantigen T cell (cNeT) therapy as a single dose in adult patients with advanced metastatic non-small cell lung cancer (NSCLC). cNeT are selectively expanded T cells that target a patient’s own clonal neoantigens which are present on all tumor cells but absent from healthy tissue. This first US patient was enrolled at the Moffitt Cancer Center in Tampa, FL where Dr. Benjamin Creelan is the Principal Investigator. CHIRON is now open at 10 sites in the UK, EU and the US.