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Achilles Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Updates

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Achilles Therapeutics (NASDAQ: ACHL) reported its Q2 2024 financial results and business updates. Key highlights include:

1. Research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines using Achilles' AI-powered technology.

2. Interim Phase I/IIa update on cNeT in Advanced NSCLC and Melanoma, with improved cNeT persistence and engraftment in patients with enhanced host conditioning (EHC).

3. Cash position of $95.1 million, supporting operations through 2025.

4. Q2 2024 financials: R&D expenses $13.6 million, G&A expenses $4.2 million, net loss $16.4 million ($0.41 per share).

5. Appointment of Matilde Saggese, MD, as Interim Chief Medical Officer.

Achilles Therapeutics (NASDAQ: ACHL) ha pubblicato i risultati finanziari del Q2 2024 e aggiornamenti aziendali. I punti salienti includono:

1. Collaborazione di ricerca con Arcturus Therapeutics per esplorare vaccini contro il cancro a mRNA di seconda generazione utilizzando la tecnologia basata sull'AI di Achilles.

2. Aggiornamento intermedio della Fase I/IIa su cNeT nel NSCLC avanzato e nel melanoma, con una maggiore persistenza e innesto di cNeT nei pazienti con condizionamento dell'ospite migliorato (EHC).

3. Posizione di liquidità di $95,1 milioni, a sostegno delle operazioni fino al 2025.

4. Finanziamenti del Q2 2024: spese R&D $13,6 milioni, spese G&A $4,2 milioni, perdita netta $16,4 milioni ($0,41 per azione).

5. Nomina di Matilde Saggese, MD, come Chief Medical Officer ad interim.

Achilles Therapeutics (NASDAQ: ACHL) reportó sus resultados financieros del Q2 2024 y actualizaciones empresariales. Los aspectos destacados incluyen:

1. Colaboración de investigación con Arcturus Therapeutics para explorar vacunas de ARN mensajero de segunda generación contra el cáncer utilizando la tecnología impulsada por IA de Achilles.

2. Actualización interina de la Fase I/IIa sobre cNeT en NSCLC avanzado y melanoma, con una mejor persistencia y injerto de cNeT en pacientes con acondicionamiento mejorado del huésped (EHC).

3. Posición de efectivo de $95,1 millones, para apoyar las operaciones hasta 2025.

4. Finanzas del Q2 2024: gastos de I+D $13,6 millones, gastos generales y administrativos $4,2 millones, pérdida neta de $16,4 millones ($0,41 por acción).

5. Nombramiento de Matilde Saggese, MD, como Directora Médica Interina.

Achilles Therapeutics (NASDAQ: ACHL)가 2024년 2분기 재무 결과와 사업 업데이트를 발표했습니다. 주요 내용은 다음과 같습니다:

1. Achilles의 AI 기반 기술을 이용한 2세대 mRNA 암 백신을 탐색하기 위해 Arcturus Therapeutics와 연구 협력.

2. 고도 진행 비소세포 폐암(NSCLC) 및 흑색종에서 cNeT의 임시 1/2a 단계 업데이트, 향상된 숙주 조건(EHC)을 가진 환자에서 cNeT 지속성과 이식률 개선.

3. 2025년까지 운영을 지원하는 $95.1 백만의 현금 보유.

4. 2024년 2분기 재무: R&D 비용 $13.6 백만, 일반 관리비 $4.2 백만, 순 손실 $16.4 백만 ($0.41 주당).

5. Matilde Saggese, MD를 임시 최고 의료 책임자로 임명.

Achilles Therapeutics (NASDAQ: ACHL) a annoncé ses résultats financiers du deuxième trimestre 2024 ainsi que des mises à jour sur ses activités. Les points saillants incluent :

1. Collaboration de recherche avec Arcturus Therapeutics pour explorer des vaccins anti-cancer à ARN messager de deuxième génération utilisant la technologie alimentée par l'IA d'Achilles.

2. Mise à jour intermédiaire de la phase I/IIa sur cNeT dans le NSCLC avancé et le mélanome, avec une amélioration de la persistance et de l'engraftment cNeT chez les patients bénéficiant d'un conditionnement de l'hôte amélioré (EHC).

3. Position de liquidités de $95,1 millions, permettant de soutenir les opérations jusqu'en 2025.

4. Finances du T2 2024 : dépenses de R&D de $13,6 millions, dépenses G&A de $4,2 millions, perte nette de $16,4 millions ($0,41 par action).

5. Nommer Matilde Saggese, MD, au poste de Directrice Médicale par intérim.

Achilles Therapeutics (NASDAQ: ACHL) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 und Unternehmensupdates veröffentlicht. Die wichtigsten Highlights sind:

1. Forschungskooperation mit Arcturus Therapeutics zur Erkundung von mRNA-Krebsimpfstoffen der zweiten Generation unter Verwendung der KI-gesteuerten Technologie von Achilles.

2. Zwischenbericht zur Phase I/IIa über cNeT bei fortgeschrittenem NSCLC und Melanomen, mit verbesserter cNeT-Persistenz und Engraftment bei Patienten mit verbessertem Wirt-Conditioning (EHC).

3. Bargeldbestand von $95,1 Millionen, der die Betriebe bis 2025 unterstützt.

4. Finanzzahlen für Q2 2024: F&E-Ausgaben $13,6 Millionen, Verwaltungskosten $4,2 Millionen, Nettoverlust $16,4 Millionen ($0,41 pro Aktie).

5. Ernennung von Matilde Saggese, MD, zur kommissarischen Chief Medical Officer.

Positive
  • Research collaboration with Arcturus Therapeutics for second-generation mRNA cancer vaccines
  • Improved cNeT persistence and engraftment in first three EHC patients
  • Cash position of $95.1 million supports operations through 2025
  • Delivered 10 products containing over 100 million cNeT and five containing over one billion cNeT
  • Slight decrease in R&D and G&A expenses compared to Q2 2023
Negative
  • Net loss of $16.4 million in Q2 2024
  • Cash and cash equivalents decreased from $131.5 million (Dec 31, 2023) to $95.1 million (Jun 30, 2024)

Insights

Achilles Therapeutics' Q2 2024 results reveal a stable financial position with $95.1 million in cash, supporting operations through 2025. The 2.4% decrease in R&D expenses to $13.6 million and slight reduction in G&A costs demonstrate efficient cost management. The net loss of $16.4 million ($0.41 per share) shows a marginal improvement from the previous year.

The collaboration with Arcturus Therapeutics for mRNA cancer vaccines could potentially open new revenue streams. However, investors should note that the company is still in the clinical stage, with no immediate revenue prospects. The focus on enhanced host conditioning (EHC) in ongoing trials could be a key differentiator if successful, potentially improving the company's market position in the competitive oncology space.

The interim Phase I/IIa data from CHIRON and THETIS trials show promising signs for Achilles' clonal neoantigen reactive T cell (cNeT) therapy. The improved cNeT persistence and engraftment in the first three EHC patients is particularly noteworthy. This could potentially lead to better clinical outcomes and differentiate Achilles in the solid tumor treatment landscape.

The collaboration with Arcturus to develop mRNA cancer vaccines targeting clonal neoantigens is a strategic move. It leverages Achilles' AI-powered tumor-targeting technology, potentially expanding their therapeutic approach beyond cell therapies. If successful, this could position Achilles as a key player in personalized cancer vaccines, a rapidly growing field in oncology.

Achilles' PELEUS platform for selecting tumor targets with high immune system recognition potential is a significant asset. Its application across various modalities (TIL, neoantigen vaccines, ADCs, TCR-T therapies) demonstrates versatility and could lead to multiple partnership opportunities.

The appointment of Dr. Matilde Saggese as Interim CMO ensures continuity in clinical development. However, investors should monitor for a permanent CMO appointment, as leadership stability is important in biotech. The company's focus on translational science and manufacturing development (VELOS™ and PELEUS™) indicates a commitment to optimizing their technology platform, which could enhance long-term competitiveness in the precision oncology market.

– Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines using Achilles’ AI-powered, tumor-targeting technology –

– Provided interim Phase I/IIa update on the use of cNeT in Advanced NSCLC and Melanoma including first patients with enhanced host conditioning (EHC), with the first three EHC patients showing improved cNeT persistence and engraftment –

– Cash position of $95.1 million supports operations through 2025 –

LONDON, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the second quarter ended June 30, 2024, and recent business highlights.

“During the second quarter we shared interim Phase I/IIa data from our ongoing CHIRON and THETIS TIL-based cNeT clinical trials and established an important research collaboration with Arcturus Therapeutics to explore the use of clonal neoantigens in second-generation personalized mRNA cancer vaccines”, said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “Our insights into the factors that drive durable engraftment and immune evasion led us to add an additional cohort in the CHIRON and THETIS trials to evaluate cNeT persistence and clinical activity in patients with enhanced host conditioning (EHC). These findings, along with the cancer vaccine research collaboration, continue to illustrate the potential value of our platform, including the unparalleled capability of PELEUS to select tumor targets with the highest potential for immune system recognition in a variety of modalities including TIL, neoantigen vaccines, ADCs, and TCR-T therapies.

Our financial position remains strong with more than $95 million in cash, which we expect to support operations through 2025, including the completion of the ongoing Phase I/IIa trials and the Arcturus collaboration.”

Clinical and Business Updates

  • Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines
    • Combines Achilles’ AI-powered, tumor-targeting technology with Arcturus’ self-amplifying mRNA platform
    • Combined technologies have the potential to generate potent and durable T cell responses in pre-clinical IND-enabling studies 
  • Provided an interim Phase I/IIa update on the use of clonal neoantigen reactive T cells (cNeT) in advanced NSCLC and melanoma
    • Dosed first EHC patients in CHIRON and THETIS, with the first three EHC patients showing improved cNeT persistence and engraftment
    • Delivered 10 products containing over 100 million cNeT and five containing over one billion cNeT
  • Matilde Saggese, MD, has been appointed as Interim Chief Medical Officer. Dr. Saggese has served as Vice President and Medical Director of Achilles Therapeutics since March 2021.

Financial Highlights

  • Cash and cash equivalents: Cash and cash equivalents were $95.1 million as of June 30, 2024, as compared to $131.5 million as of December 31, 2023. The Company believes that its cash and cash equivalents are sufficient to fund its planned operations through 2025.
  • Research and development (R&D) expenses: R&D expenses were $13.6 million for the second quarter ended June 30, 2024, compared to $13.8 million for the second quarter ended June 30, 2023. The decrease was primarily driven by decreased activity in THETIS and lower personnel costs, partially offset by increased activity in CHIRON.
  • General and administrative (G&A) expenses: G&A expenses were $4.2 million for the second quarter ended June 30, 2024, compared to $4.3 million for second quarter ended June 30, 2023. This decrease was primarily driven by lower personnel costs and lower insurance premiums.
  • Net loss: Net loss for the second quarter ended June 30, 2024 was $16.4 million or $0.41 per share compared to $16.8 million or $0.42 per share for the second quarter ended June 30, 2023.

2024 Focus

  • Clinical Data: Report clinical activity and translational science data from patients in CHIRON and THETIS, evaluating the benefit of EHC, with a meaningful data update expected in the second half of 2024
  • Arcturus Collaboration: Ongoing evaluation of best-in-class, self-amplifying mRNA (sa-mRNA) personalized cancer vaccines (PCVs) targeting clonal neoantigens with the potential to generate IND-enabling data
  • Translational Science: Leverage the Company’s unique bioinformatics platform to better understand the drivers associated with clinical responses
  • Manufacturing Development: Continue VELOS™ and PELEUS™ development to optimize cNeT dose and functionality

About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing AI-powered 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. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing of the Company’s clinical and translational data updates and the Company’s beliefs about recent data updates, and expectations related to the Company’s cash runway and operating expenses and capital expense requirements. 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.

For further information, please contact:

Investors:
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com

Media:
ICR Consilium
Sukaina Virji, Tracy Cheung, Dylan Wilks
+44 (0) 203 709 5000
achillestx@consilium-comms.com

 
ACHILLES THERAPEUTICS PLC
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
 
      June 30,  December 31,
   2024   2023 
ASSETS    
CURRENT ASSETS:    
Cash and cash equivalents $                95,111  $            131,539 
Prepaid expenses and other current assets                     22,706                     14,094 
    Total current assets                  117,817                  145,633 
Property and equipment, net                        6,954                        9,171 
Operating lease right of use assets                        4,165                        4,372 
Deferred tax assets                                41                                41 
Restricted cash                                53                                33 
Other assets                        2,156                        2,206 
    Total non-current assets                     13,369                     15,823 
    Total assets $             131,186  $            161,456 
LIABILITIES AND SHAREHOLDERS’ EQUITY    
CURRENT LIABILITIES:    
Accounts payable $                   2,865  $                  5,629 
Accrued expenses and other liabilities                        7,225                        7,828 
Operating lease liabilities - current                        4,205                        3,539 
    Total current liabilities                     14,295                     16,996 
NON-CURRENT LIABILITIES:    
Operating lease liabilities - non-current                             258                        1,076 
Other long-term liability                        1,158                        1,015 
       Total non-current liabilities                        1,416                        2,091 
       Total liabilities                     15,711                     19,087 
     
Commitments and contingencies    
SHAREHOLDERS’ EQUITY:    
Ordinary shares, £0.001 par value;  41,087,901 and 41,082,948 shares authorized,
   issued and outstanding at June 30, 2024 and December 31, 2023, respectively
                                54                                54 
Deferred shares, £92,451.85 par value, one share authorized,  issued and outstanding
   at June 30, 2024 and December 31, 2023, respectively
                             128                             128 
Additional paid in capital                  417,914                  415,210 
Accumulated other comprehensive income                   (14,015)                  (13,071)
Accumulated deficit                (288,606)               (259,952)
    Total shareholders’ equity                  115,475                  142,369 
    TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $             131,186  $            161,456 


 
ACHILLES THERAPEUTICS PLC
 
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
     
   Three Months Ended    Six Months Ended 
   June 30,    June 30, 
   2024   2023   2024   2023 
 OPERATING EXPENSES:       
 Research and development$          13,635  $          13,774  $          23,775  $          27,642 
 General and administrative                 4,164                   4,318                8,323                   9,003 
      Total operating expenses              17,799                18,092                32,098                36,645 
 LOSS FROM OPERATIONS:            (17,799)             (18,092)             (32,098)             (36,645)
 OTHER INCOME (EXPENSE), NET:       
 Other income (expense)                 1,427                   1,212                   3,429                   2,303 
      Total other income (expense), net                 1,427                   1,212                   3,429                   2,303 
 Loss before income taxes            (16,372)             (16,880)             (28,669)             (34,342)
 (Provision) benefit for income taxes                      (8)                         34                        15                        (10)
 Net loss             (16,380)             (16,846)             (28,654)             (34,352)
 Other comprehensive (loss) income:       
 Foreign exchange translation adjustment                     195                   3,817                     (944)                  7,794 
 Comprehensive loss$        (16,185) $        (13,029) $        (29,598) $        (26,558)
 Net loss per share attributable to ordinary shareholders—basic and diluted$              (0.41) $             (0.42) $             (0.71) $             (0.86)
 Weighted average ordinary shares outstanding—basic and diluted   40,355,972     39,899,944     40,318,690     39,816,528 

                                                   


FAQ

What was Achilles Therapeutics' (ACHL) cash position as of June 30, 2024?

Achilles Therapeutics reported a cash position of $95.1 million as of June 30, 2024, which is expected to support operations through 2025.

What is the focus of Achilles Therapeutics' (ACHL) collaboration with Arcturus Therapeutics?

The collaboration aims to explore second-generation mRNA cancer vaccines by combining Achilles' AI-powered, tumor-targeting technology with Arcturus' self-amplifying mRNA platform.

What were the key financial results for Achilles Therapeutics (ACHL) in Q2 2024?

In Q2 2024, Achilles Therapeutics reported R&D expenses of $13.6 million, G&A expenses of $4.2 million, and a net loss of $16.4 million or $0.41 per share.

What clinical updates did Achilles Therapeutics (ACHL) provide in their Q2 2024 report?

Achilles provided an interim Phase I/IIa update on cNeT in Advanced NSCLC and Melanoma, reporting improved cNeT persistence and engraftment in the first three patients with enhanced host conditioning (EHC).

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