ACHL Achilles Therapeutics plc

4.84
-0.35  -7%
Previous Close 5.19
Open 5.07
52 Week Low 4.565
52 Week High 18.9476
Market Cap $196,520,887
Shares 40,603,489
Float 40,603,489
Enterprise Value $-57,735,893
Volume 63,142
Av. Daily Volume 301,357
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Drug Pipeline

Drug Stage Notes
ATL001 - CHIRON
Non Small Cell Lung Cancer
Phase 1/2
Phase 1/2
Phase 1/2a update reported stable disease in 63% (5 of 8) in this initial, low-dose cohort, noted November 12, 2021.
ATL001 - THETIS
Melanoma
Phase 1/2
Phase 1/2
Phase 1/2a update reported stable disease in 63% (5 of 8) in the initial, low-dose cohort noted November 12, 2021.

Latest News

  1. LONDON, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today presented two posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting demonstrating the ability to detect, quantify, and track patient-specific clonal neoantigen-reactive T cells (cNeT) and generate increased cNeT doses from VELOS™ Process 2 manufacturing. cNeT target clonal neoantigens, which are unique targets expressed on every cancer cell within a patient but not on healthy tissue.

    Samra Turajlic, MD, PhD, Chief Investigator for Achilles' Phase I/IIa THETIS trial for metastatic malignant melanoma at the Royal Marsden NHS Foundation…

    LONDON, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today presented two posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting demonstrating the ability to detect, quantify, and track patient-specific clonal neoantigen-reactive T cells (cNeT) and generate increased cNeT doses from VELOS™ Process 2 manufacturing. cNeT target clonal neoantigens, which are unique targets expressed on every cancer cell within a patient but not on healthy tissue.

    Samra Turajlic, MD, PhD, Chief Investigator for Achilles' Phase I/IIa THETIS trial for metastatic malignant melanoma at the Royal Marsden NHS Foundation Trust in London, UK, presented Poster 543, entitled ‘Sensitive quantification and tracking of the active components of a clonal neoantigen T cell (cNeT) therapy: From manufacture to peripheral circulation' which shows Achilles' ability to detect, quantify and track patient-specific cNeT pre- and post-infusion in the ongoing PI/IIa CHIRON and THETIS clinical trials for non-small cell lung cancer (NSCLC) and metastatic malignant melanoma, respectively. Joseph Robinson, PhD, Senior Scientist, Process Development at Achilles Therapeutics, presented Poster 193, ‘The Achilles VELOS™ Process 2 boosts the dose of highly functional clonal neoantigen-reactive T cells for precision personalized cell therapies' highlighting data from a proof-of-concept study showing an 18-fold increase in median cNeT generated from VELOS™ Process 2 compared to Process 1.

    "The data we presented today continue to illustrate the differentiated profile of our cNeT product and overall platform that builds on standard TIL therapy by leveraging clonal neoantigen targeting to deliver a more precise and potent product," said Dr Iraj Ali, Chief Executive Officer of Achilles. "The ability to reliably detect and quantify our active component is a key differentiator of our world-class technology that is unique in the field and which we believe will be critical for the successful development of TIL-based therapies."

    Engraftment Kinetics, Quantification and Tracking of cNeT in CHIRON and THETIS

    Data presented from the first eight patients dosed across the first-in-human PI/IIa CHIRON and THETIS trials confirm the ability of Achilles' VELOS manufacturing process to generate fit, polyclonal cNeT that can target multiple cancer neoantigens present on all tumor cells. Achilles' platform can detect, quantify and track the patient-specific cNeT during manufacturing and post patient administration, allowing for extensive product characterization and immune-monitoring.

    At the data cut-off for this presentation, five patients with melanoma (THETIS) and three patients with NSCLC (CHIRON) had received their cNeT infusion. The median age of the cohort was 57 years and patients had received a median of 2.5 lines of prior therapy. 88% (7 of 8) of the cNeT products dosed targeted multiple clonal neoantigens present on all tumor cells. In these seven products, the number of individual reactivities ranged from two to twenty-eight and cNeT were detected in the blood of 71% (5 of 7) of the patients following infusion at time points up to six weeks post dosing. Best response in the eight dosed patients was stable disease in 63% (5 of 8) in this initial, low-dose cohort generated using VELOS Process 1. The tolerability profile was generally similar to that of standard TIL products that have not been enriched for cNeT reactivity, with none of the higher-grade adverse events more commonly associated with the use of higher doses of interleukin-2 (IL-2). There were no suspected unexpected serious adverse reactions reported since the previous update on the first six patients earlier in 2021. Overall, in the cohort there were three events of cytokine release syndrome and one ICANS event deemed to be possibly related to cNeT treatment. A previously disclosed case of encephalopathy was subsequently deemed unlikely related to cNeT treatment following an Independent Data Safety Monitoring Committee review.

    "The encouraging data from this low-dose cohort are important as they show how the Achilles platform can answer potency questions, gives a first look at mechanism of action in a TIL product, and adds confidence to now move to higher cell doses," said Dr Samra Turajlic, THETIS Chief Investigator, Royal Marsden NHS Foundation Trust, London, UK. "I look forward to exploring higher median doses from VELOS Process 2 manufacturing that should more predictably be in the anticipated therapeutic range, based on work done with other cell therapies. As we move to higher cNeT doses I expect improved cellular engraftment, both in terms of peak expansion and durability, and hope to see greater evidence of anti-tumor activity."

    The median cNeT dose in patients in this low-dose, Process 1 cohort was 14.2 million cNeT, which is in line with previous updates. VELOS Process 1 manufacturing generated doses between 0.1 million and 287 million cNeT. cNeT reactivity, defined as the percentage of clonal neoantigen-reactive cells in the final dosed products, ranged from 5% to 77%. As the dataset expands and matures, these metrics of detection and expansion will be correlated with product, clinical and genomic characteristics to determine variables associated with peripheral cNeT dynamics and clinical response.

    VELOS™ Process 2 Manufacturing

    Achilles' VELOS Process 2 manufacturing generated an 18-fold increase in cNeT compared to Process 1 in this proof-of-concept study. The increased cNeT contained multiple polyclonal reactivities and key phenotypic features associated with high cell fitness and reduced cell exhaustion. VELOS Process 2 improves upon Process 1 by introducing additional culture media supplementation and an expansion-boosting stimulation cocktail during the co-culture period, without adding any time to the overall manufacturing process. Complementary GMP scale manufacturing data from Process 2 will be presented at the ESMO Immuno-Oncology Congress taking place December 8-11, 2021. This GMP scale manufacturing is identical to the process for Achilles' clinical studies and formed the basis of the Company's regulatory submissions to move the ongoing clinical studies to Process 2.

    "We are thrilled to see that our Process 2 generated such a robust increase in cells while maintaining a highly functional phenotype and we look forward to treating patients with higher doses manufactured using VELOS Process 2," said Dr Sergio Quezada, Chief Scientific Officer of Achilles. "Based on our experience with other cell therapies, we are confident that Process 2 will deliver doses able to elicit detectable clinical activity."

    Achilles' proprietary potency assay enabled the quantification of the proportion of tumor reactive cNeT within the expanded TIL population. Both processes generated CD4+ and CD8+ cells able to recognize clonal neoantigens. Process 2 delivered a polyclonal product with a median of five neoantigen reactivities (range 3 to 18) detected per patient. The immunophenotype of cNeT generated by Process 1 and 2 was largely similar, with the majority of the cells bearing an effector memory phenotype. Cells generated from both processes are also functionally similar as determined by their ability to secrete INF-γ, IL-2 and TNF-α in response to polyclonal stimulus.

    Poster presentations are available in the Events & Presentations section of the Company website.

    Webcast and Conference Call Details

    The company will host a live webcast and conference call today, Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to review the SITC presentations and provide a corporate update. A slide presentation to accompany today's webcast and conference call will be available on the webcast and in the Events & Presentations section of the Company's website. The live webcast can be accessed in the Events & Presentations section of the Company's website. The conference call dial-in 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.

    About Achilles Therapeutics

    Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with unresectable locally advanced and metastatic non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

    Forward-Looking Statements

    This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Further information:

    Lee M. Stern – VP, IR & External Communications

    +1 (332) 373-2634

    Consilium Strategic Communications

    Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner

    +44 (0) 203 709 5000



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    • Secarna's LNAplusTM ASOs have the potential to optimize personalized T cell therapies being developed by Achilles
    • Secarna's industry-leading antisense oligonucleotide (ASO) platform LNAplusTM enables discovery and research of ASOs against undisclosed targets in the area of immune oncology

    MUNICH, GERMANY and MARTINSRIED, GERMANY / ACCESSWIRE / November 10, 2021 / Secarna Pharmaceuticals GmbH & Co. KG ("Secarna"), a biopharmaceutical company focusing on the discovery and development of next-generation antisense oligonucleotide (ASO) therapies to address challenging or previously undruggable targets, today announced that the Company has entered into a research, option and license agreement with Achilles Therapeutics UK Limited ("Achilles"), a member…

    • Secarna's LNAplusTM ASOs have the potential to optimize personalized T cell therapies being developed by Achilles
    • Secarna's industry-leading antisense oligonucleotide (ASO) platform LNAplusTM enables discovery and research of ASOs against undisclosed targets in the area of immune oncology

    MUNICH, GERMANY and MARTINSRIED, GERMANY / ACCESSWIRE / November 10, 2021 / Secarna Pharmaceuticals GmbH & Co. KG ("Secarna"), a biopharmaceutical company focusing on the discovery and development of next-generation antisense oligonucleotide (ASO) therapies to address challenging or previously undruggable targets, today announced that the Company has entered into a research, option and license agreement with Achilles Therapeutics UK Limited ("Achilles"), a member of the Achilles Therapeutics plc (NASDAQ:ACHL) group of companies, in the field of immune oncology.

    Secarna will employ its commercially validated discovery and development platform, LNAplusTM, to generate ASO candidates against selected targets that potentially play a central role in the ex vivo optimization of personalized T cell therapies being developed by Achilles. Following in vitro testing performed by Secarna, Achilles will conduct production feasibility and optimization testing.

    Under the terms of the agreement, Secarna will receive an undisclosed upfront payment, a target-based technology access fee as well as option exercise fees. Secarna is also eligible to receive development and commercial milestone payments as well as tiered royalties on net sales of personalized T cell therapies developed and commercialized under this collaboration.

    "We are excited to collaborate with Achilles and jointly work on a highly innovative approach to optimize T cell therapies with our LNAplusTM-based ASOs," said Alexander Gebauer, M.D., Ph.D., CEO of Secarna Pharmaceuticals. "By combining our industry-leading antisense oligonucleotide platform with Achilles' expertise in the field of T cell therapies, we see the potential to break new ground in the treatment of cancer patients."

    About Secarna's proprietary drug discovery and development platform, LNAplus(TM)

    Secarna's proprietary, customized LNAplusTM platform is being applied to the discovery, testing and selection of antisense oligonucleotides (ASOs) for pre-clinical and clinical development. LNAplusTM encompasses all aspects of drug discovery and pre-clinical development and has proven to be fast, reliable, scalable and efficient, enabling the discovery of novel antisense-based therapies for challenging or currently undruggable targets.The platform includes the powerful proprietary OligofyerTM bioinformatics pipeline, a streamlined, high efficiency screening process, including Secarna's proprietary LNA-Vit(r)oxTM safety test system, as well as target-specific functional assays. Secarna's platform and ASOs have been validated by numerous in-house projects as well as in several academic and industry collaborations.

    About Secarna Pharmaceuticals GmbH & Co. KG

    Secarna Pharmaceuticals is the leading independent European next-generation antisense drug discovery and development company addressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna's mission is to maximize the performance and output of its proprietary LNAplus(TM) antisense oligonucleotide discovery platform, as well as to develop highly specific, safe, and efficacious best-in-class antisense therapies. With over 15 development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where antisense-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com

    About Achilles Therapeutics plc

    Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with unresectable locally advanced and metastatic non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS(TM) bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

    Contact:

    Secarna Pharmaceuticals GmbH & Co. KG
    Alexander Gebauer, MD, PhD
    CEO

    Secarna Pharmaceuticals GmbH & Co. KG
    Am Klopferspitz 19
    82152 Planegg/Martinsried
    Tel.: +49 (0)89 215 46 375

    For media enquiries:
    Anne Hennecke/Vera Lang
    MC Services AG

    Tel.: +49 211 529252 15

    SOURCE: Secarna Pharmaceuticals GmbH & Co. KG



    View source version on accesswire.com:
    https://www.accesswire.com/672099/Secarna-Pharmaceuticals-and-Achilles-Therapeutics-Sign-Research-Option-and-License-Agreement-to-Develop-Optimized-T-Cell-Therapies

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  2. - Oral Presentation at European Society for Gene and Cell Therapy (ESGCT) demonstrated ability to generate potent anti-cancer cell therapy candidates in multiple solid tumor types -

    - Society for Immunotherapy of Cancer (SITC) abstracts highlight the ability to detect, quantify and track patient-specific cNeT and generate increased cNeT doses from VELOS™ Process 2 manufacturing -

    - Conference call and webcast scheduled for Friday, November 12, 2021 at 8:30am ET to review SITC presentations and provide a corporate update -

    LONDON, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced its financial…

    - Oral Presentation at European Society for Gene and Cell Therapy (ESGCT) demonstrated ability to generate potent anti-cancer cell therapy candidates in multiple solid tumor types -

    - Society for Immunotherapy of Cancer (SITC) abstracts highlight the ability to detect, quantify and track patient-specific cNeT and generate increased cNeT doses from VELOS™ Process 2 manufacturing -

    - Conference call and webcast scheduled for Friday, November 12, 2021 at 8:30am ET to review SITC presentations and provide a corporate update -

    LONDON, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced its financial results for the third quarter ended September 30, 2021, and recent business highlights.

    "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 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, 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 Immuno-Oncology Congress taking place December 8-11, 2021."

    Business Highlights

    • Two abstracts for the SITC 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) 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 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.

    About Achilles Therapeutics 

    Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

    Forward-Looking Statements 

    This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Further information:

    Lee M. Stern – VP, IR & External Communications

    +1 (332) 373-2634

    Consilium Strategic Communications

    Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner

    +44 (0) 203 709 5000

    ACHILLES THERAPEUTICS PLC

    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands, except share and per share amounts)

    (expressed in U.S. Dollars, unless otherwise stated)

      September 30,  December 31, 
      2021  2020 
    ASSETS        
    Current assets:        
    Cash and cash equivalents $281,875  $177,849 
    Prepaid expenses and other current assets  16,401   9,948 
    Total current assets  298,276   187,797 
    Non-current assets:        
    Property and equipment, net  16,378   13,369 
    Operating lease right of use assets  11,938   14,740 
    Deferred tax assets  4   4 
    Restricted cash  33    
    Other assets  3,370   3,008 
    Total non-current assets  31,723   31,121 
    TOTAL ASSETS $329,999  $218,918 
    LIABILITIES AND SHAREHOLDERS' EQUITY        
    Current liabilities:        
    Accounts payable $2,460  $6,314 
    Income taxes payable  36   7 
    Accrued expenses and other liabilities  8,472   6,590 
    Operating lease liabilities-current  4,398   3,712 
    Total current liabilities  15,366   16,623 
    Non-current liabilities:        
    Operating lease liabilities-non-current  8,881   12,271 
    Other long-term liability  643   652 
    Total non-current liabilities  9,524   12,923 
    Total liabilities  24,890   29,546 
    Commitments and contingencies (Note 12)        
    Shareholders' equity:        
    Ordinary shares, £0.001 par value; 40,603,489 and 4,389,920 shares

     authorized, issued and outstanding at September 30, 2021 and December

     31, 2020, respectively
      54   6 
    Deferred shares, £92,451.851 par value, one share authorized, issued and

    outstanding at September 30, 2021; Deferred shares, £0.001 par value;

    30,521 shares issued and outstanding December 31, 2020
      128    
    Convertible preferred shares, £0.001 par value; no shares authorized,

    issued and outstanding as of September 30, 2021;104,854,673 shares

    authorized, issued and outstanding at December 31, 2020
         134 
    Additional paid in capital  400,058   234,922 
    Accumulated other comprehensive income  5,750   12,322 
    Accumulated deficit  (100,881)  (58,012)
    Total shareholders' equity  305,109   189,372 
    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $329,999  $218,918 
             

    ACHILLES THERAPEUTICS PLC

    Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended September 30,  Nine Months Ended September 30, 
      2021  2020  2021  2020 
    OPERATING EXPENSES:                
    Research and development $10,697  $5,291  $30,417  $13,668 
    General and administrative  5,041   3,009   15,318   7,140 
    Total operating expenses  15,738   8,300   45,735   20,808 
    Loss from operations  (15,738)  (8,300)  (45,735)  (20,808)
    OTHER INCOME, NET:                
    Other income  2,806   90   2,907   529 
    Total other income, net  2,806   90   2,907   529 
    Loss before provision for income taxes  (12,932)  (8,210)  (42,828)  (20,279)
    Provision for income taxes  (16)     (41)   
    Net loss  (12,948)  (8,210)  (42,869)  (20,279)
    Other comprehensive income:                
    Foreign exchange translation adjustment  (7,710)  3,501   (6,572)  (3,088)
    Comprehensive loss $(20,658) $(4,709) $(49,441) $(23,367)
    Net loss per share attributable to ordinary shareholders—basic and diluted $(0.34) $(7.50) $(1.69) $(21.16)
    Weighted average ordinary shares outstanding—basic and diluted  38,261,480   1,094,543   25,329,672   958,373 
                     


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  3. CAMBRIDGE, England, Nov. 1, 2021 /PRNewswire/ -- Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the appointment of a Chief Business Officer (CBO), Beverley Carr.

    Amphista's CEO Dr Nicola Thompson said, "On behalf of the Amphista team, I am thrilled to welcome Beverley as our CBO.  Beverley brings a wealth of business development expertise from an impressive career as a business leader, spanning both global Pharma and Biotech. Beverley's leadership of this strategically important function will be key to ensuring that the full potential of our proprietary next generation TPD technology is captured across therapy areas in order to bring transformative medicines to patients."

    Amphista's…

    CAMBRIDGE, England, Nov. 1, 2021 /PRNewswire/ -- Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the appointment of a Chief Business Officer (CBO), Beverley Carr.

    Amphista's CEO Dr Nicola Thompson said, "On behalf of the Amphista team, I am thrilled to welcome Beverley as our CBO.  Beverley brings a wealth of business development expertise from an impressive career as a business leader, spanning both global Pharma and Biotech. Beverley's leadership of this strategically important function will be key to ensuring that the full potential of our proprietary next generation TPD technology is captured across therapy areas in order to bring transformative medicines to patients."

    Amphista's new CBO, Beverley Carr, commented on her appointment, "I'm delighted to join Amphista's world class team. Amphista is founded on transformational science and I'm looking forward to driving the Company's business development strategy as we execute our mission of building the leading TPD company." 

    Beverley joins Amphista from Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company, where she was CBO. Previously Beverley was Vice President Business Development for the Immunoinflammation Therapy Area at GSK, where she led over twenty transactions for the immune-inflammation therapy area. Beverley has negotiated and closed major deals across all stages of drug discovery and development. She is a scientist by training with an MA and DPhil in chemistry from Oxford University and has an MBA from Cambridge University.

    Media contacts:

    Amphista Therapeutics

    CEO NicolaThompson

    Scius Communications

    Katja Stout

    About Amphista Therapeutics

    Amphista Therapeutics is focused on transforming the lives of patients with severe diseases including cancer. The company is applying its proprietary Amphista degrader platform to advance new approaches in targeted protein degradation (TPD), which address the challenges faced by the field and to realise the full therapeutic potential of this transformational approach. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli's labs at the University of Dundee. The company has raised over $60M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly & Company.

    For more information, please visit: http://www.amphista.com/

    Cision View original content:https://www.prnewswire.com/news-releases/amphista-therapeutics-appoints-cbo-beverley-carr-301412106.html

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  4. LONDON, Oct. 22, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today delivered an oral presentation (OR54) at the 2021 European Society for Gene and Cell Therapy (ESGCT) Congress. In the presentation entitled ‘Multicentre, prospective research protocol for development of a clonal neoantigen-reactive T cell (cNeT) therapy pipeline across multiple tumour types,' Dr. Michael Grant, Associate Medical Director at Achilles, reviewed initial data from the Company's Material Acquisition Platform (MAP)​ showing that Achilles' proprietary VELOS™ manufacturing process is able to extract tumor infiltrating lymphocytes (TIL) and generate…

    LONDON, Oct. 22, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ:ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today delivered an oral presentation (OR54) at the 2021 European Society for Gene and Cell Therapy (ESGCT) Congress. In the presentation entitled ‘Multicentre, prospective research protocol for development of a clonal neoantigen-reactive T cell (cNeT) therapy pipeline across multiple tumour types,' Dr. Michael Grant, Associate Medical Director at Achilles, reviewed initial data from the Company's Material Acquisition Platform (MAP)​ showing that Achilles' proprietary VELOS™ manufacturing process is able to extract tumor infiltrating lymphocytes (TIL) and generate potent clonal neoantigen-reactive T cells (cNeT) across a range of solid tumor types. cNeT target clonal neoantigens, which are unique proteins expressed on every cancer cell within a patient but not on healthy tissue.

    MAP is a unique prospective study that facilitates the procurement of patient material across a range of solid tumor types, enabling a comprehensive evaluation of indications prior to clinical development. MAP was developed to enable the detailed genomic and cellular characterization of different cancer tissue types and assess the ability to produce significant doses of potent cNeT. The study is currently collecting patient material at eight sites in the United Kingdom, European Union, and United States from patients with a range of cancers including lung, melanoma, head and neck, renal, bladder and breast cancer.

    "This important research shows that our bioinformatics and manufacturing processes together produce fit, potent and neoantigen-specific cells and supports the potential use of our cNeT in a broad range of solid tumor indications beyond our current clinical trials in non-small cell lung cancer (NSCLC) and metastatic melanoma, and into indications including head and neck cancer," said Dr Sergio Quezada, Chief Scientific Officer of Achilles. "MAP showcases the analytical strength of the Achilles platform, delivers vital translational science insights, and highlights our organizational and supply chain expertise. It has been extremely successful in accumulating a broad set of tumor-related material and continues to expand into new countries and indications."

    Data presented show that the VELOS manufacturing process delivers higher neoantigen-specificity and potency, in both CD4+ and CD8+ T cell activity, relative to traditionally manufactured TIL products from the same tumor source material. These enhancements can be seen in specificity and potency assays in which IFN-γ and TNF-α cytokine secretion and production of inflammatory cytokines is triggered in response to clonal neoantigen presentation. Additionally, analysis of CD4+ and CD8+ cells in cNeT products shows favorable cell phenotypes consistent with high cell fitness and reduced cell exhaustion. At the time of submission, 74 patient samples had been processed across five solid tumor indications. The proprietary PELEUSTM platform identified a median of 107 clonal neoantigens in NSCLC samples, 156 in melanoma samples, and 71 in head and neck squamous cell carcinoma samples, consistent with publicly available data sets, illustrating the accuracy of the platform. Additional data for renal and bladder tumor samples were still in process at the time of submission.

    The presentation delivered by Dr. Grant is available in the Events & Presentations section of the Achilles Therapeutics website.

    About Achilles Therapeutics

    Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with unresectable locally advanced and metastatic non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

    Forward-Looking Statements

    This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Further information:

    Lee M. Stern – VP, IR & External Communications

    +1 (332) 373-2634

    Consilium Strategic Communications

    Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner

    +44 (0) 203 709 5000



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