Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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). Board Change • May 08
High number of new directors Member of Scientific Advisory Board Alena Gros was the last director to join the board, commencing their role in 2022. Board Change • Mar 28
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. Board Change • Feb 17
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. Board Change • Aug 11
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. Board Change • May 09
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.