On November 9, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the third quarter ended September 30, 2021, and recent business highlights (Press release, Achilles Therapeutics, NOV 9, 2021, View Source [SID1234594885]).
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"We have continued to make good progress during the third quarter and will share an update from the first eight patients across our CHIRON (non-small cell lung cancer, or NSCLC) and THETIS (melanoma) studies at the upcoming SITC (Free SITC Whitepaper) meeting. Our unique ability to accurately quantify the tumor reactive component of each product and to track clonal neoantigen reactive T cells (cNeT) in the patients post-dosing is possible through the detailed genomic analysis of the tumor and prospective clonal neoantigen targeting afforded by our proprietary bioinformatics platform. We believe this best-in-class analytical capability will be critical for the successful development of TIL-based therapies," said Dr Iraj Ali, Chief Executive Officer of Achilles. "At SITC (Free SITC Whitepaper), we will also share details of our VELOS Process 2 manufacturing, which is able to routinely generate significantly higher doses of cNeT than our current Process 1. We will present further GMP scale data from VELOS Process 2 at the upcoming ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress taking place December 8-11, 2021."
Business Highlights
Two abstracts for the SITC (Free SITC Whitepaper) 36th Annual Meeting were published today – Poster 543, underscoring the ability to sensitively detect, quantify and track patient-specific cNeT during manufacture and post dosing, and Poster 193, highlighting our ability to generate increased doses of reactive cNeT from VELOS Process 2
Delivered an oral presentation at the 2021 European Society for Gene and Cell Therapy (ESGCT) Congress entitled, "Multicentre, prospective research protocol for development of a clonal neoantigen-reactive T cell therapy pipeline across multiple tumour types" highlighting the Company’s Material Acquisition Platform (MAP) and supporting the potential use of cNeT in a broad range of solid tumor indications
Granted US patent US 11,098,121 and European patent EP3347039B covering a method of identifying cancer patients that are likely to respond to a checkpoint inhibitor (CPI) by determining the total number of clonal neoantigens or the ratio of clonal to sub-clonal neoantigens in patients’ cancer cells
Enrolled the first patient in the United States at the Moffitt Cancer Center in the Phase I/IIa CHIRON clinical trial
In-licensed from Secarna Pharmaceuticals GmbH & Co antisense oligonucleotide technology and intellectual property for the ex vivo manufacture of a T cell pharmaceutical product
Financial Highlights
Cash and cash equivalents: Cash and cash equivalents were $281.9 million as of September 30, 2021, as compared to $177.8 million as of December 31, 2020. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials
Research and development (R&D) expenses: R&D expenses were $10.7 million for the third quarter ended September 30, 2021, an increase of $5.4 million compared to $5.3 million for the third quarter ended September 30, 2020. R&D expenses were $30.4 million for the nine months ended September 30, 2021, an increase of $16.7 million compared to $13.7 million for the nine months ended September 30, 2020. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D
General and administrative (G&A) expenses: G&A expenses were $5.0 million for the third quarter ended September 30, 2021, an increase of $2.0 million compared to $3.0 million for the third quarter ended September 30, 2020. G&A expenses were $15.3 million for the nine months ended September 30, 2021, an increase of $8.2 million compared to the $7.1 million for the nine months ended September 30, 2020. The increase was primarily driven by fees associated with the Company’s public company obligations, and an increase in headcount and related personnel costs
Net loss: Net loss for the third quarter ended September 30, 2021 was $12.9 million or $0.34 per share compared to $8.2 million or $7.50 per share for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021 was $42.9 million or $1.69 per share compared to $20.3 million or $21.16 per share for the nine months ended September 30, 2020. The decrease in loss per share is due in part to the increased number of shares following the conversion and issuance of shares from the IPO
Upcoming Events
Achilles will present at the following medical and investor conferences in November and December 2021. Additional details will be available in the Events & Presentations section of the Company’s website:
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting: November 10 – 14, 2021
Piper Sandler Annual Healthcare Conference: November 29 – December 2, 2021
ESMO Immuno-Oncology Congress 2021: December 8 – 11, 2021
In addition, the Company will host a live webcast and conference call on Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to review the SITC (Free SITC Whitepaper) presentations and provide a corporate update. The live webcast can be accessed in the Events & Presentations section of the Company’s website. The conference call dial-in numbers for investors and analysts are (833) 732-1204 (toll free within the USA), 0800 0288438 (toll free within the United Kingdom) or (720) 405-2169 (outside the USA) with the access code 4795875.