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Interim Results

pre|CISION™ enabled peptide drug conjugate AVA6000 continues to demonstrate a highly encouraging tolerability profile with robust preliminary efficacy signals in both dose escalation arms of Phase 1a trial 

Continued strong clinical performance supports broader confidence in the pre|CISION™ platform 

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announces its unaudited interim results for the six months ending 30 June 2024 (“H1 2024”) with recent progress against the Company’s 2024 stated goals.

Operational developments 

  • Enrollment in the AVA6000 Phase 1a dose escalation trial of AVA6000, a peptide drug conjugate enabled by the pre|CISION™ platform, has completed with no maximum tolerated dose (“MTD”) identified. A favorable safety profile was reported
  • Multiple durable RECIST responses were observed in patients with high-grade sarcoma and salivary gland cancers, indicating that tumor cell expression of FAP is not required for the release of doxorubicin, with even lower levels of stroma-only expression being sufficient
  • Enrollment in the recommended dose for expansion (RDE) cohort is ongoing, focusing on patients with high-grade sarcomas and a subset of head and neck cancer (salivary gland cancer)
  • Formation of Scientific Advisory Board (“SAB”) chaired by William D. Tap MD, Chief of the Sarcoma Oncology Service at the Memorial Sloan Kettering Cancer Center in New York City to guide the ongoing clinical development of AVA6000 and the pre|CISION™ platform

 

Financial highlights

  • Financial performance of the Group in line with the Board’s expectations
  • Revenues of £11.3 million (H1 2023: £11.9 million; FY 2023: £23.3 million)
  • R&D expenditure of £6.7 million (H1 2023: £6.0 million; FY 2023: £14.5 million)
  • Adjusted EBITDA loss (before non-cash and non-recurring items) of £11.1 million (H1 2023: £7.9 million; FY 2023: £20.1 million)
  • Reported loss of £12.5 million (H1 2023: £11.5 million; FY 2023: £25.0 million)
  • Loss per ordinary share of 3.8p (H1 2023: loss 4.3p; FY 2023: loss 9.2p)
  • Fundraise completed in March 2024 raising £31.1 million (gross)
  • Cash and cash equivalents of £32.5 million (30 June 2023: £26.0 million; 31 December 2023: £16.6 million)
  • Events after the reporting period:
    • In July 2024, settlement in cash of the quarterly amortization payment of £3.08 million in connection with the Group’s convertible bond
  • Diagnostics division revenue grew to £11.2 million (H1 2023: £9.9 million; year ended 31 December 2023, FY 2023: £21.2 million). Adjusted EBITDA improved to a profit of £0.1 million (H1 2023: loss of £0.4 million; FY 2023: loss of £1.2 million)

 Outlook

  • At the half year stage, the data from the ongoing Phase 1a clinical study of AVA6000 continues to support Avacta’s growing confidence in AVA6000 and the wider potential of the pre|CISION™ platform
  • A process to divest the Group’s Diagnostics division has commenced in order to maximize value for shareholders, ensure our focus as a therapeutics-focused Company and support our appeal to specialist international investors
  • The Board of Directors is also exploring opportunities for a dual listing on NASDAQ and an update on this aspect of the Group’s longer-term financing strategy will be provided in due course

Shaun Chilton, Chairman of Avacta Group plc commented:

“Over the four months since Chris Coughlin’s and my appointments, we have made significant progress on key strategic priorities. Alongside the Board and wider team, we have carried out a detailed review of all the Group’s operations and financials with a focus on prioritizing further investments in therapeutics, including the acceleration of the AVA6000 clinical trial enrollment.   

“We are very encouraged by the potential of the innovative medicines in the Avacta pipeline which we plan to present at our live R&D Spotlight in October focusing on the Next Generation of the pre|CISION™ platform. 

“We have commenced a process to divest the Diagnostics Division and have started to receive indicative offers. Our longer-term financing strategy is being formulated and includes a potential dual listing of the Company on NASDAQ, which the Board sees as a key strategic option for the Company.”

Christina Coughlin, MD, PhD, Chief Executive Officer of Avacta Group plc, commented: 

“We are seeing notably positive progress on our drug development candidate AVA6000 with the completion of the Phase 1a trial with no maximum tolerated dose and opening of the RDE expansion.  This novel peptide drug conjugate continues to demonstrate a highly favorable tolerability profile and robust preliminary signs of efficacy, with several durable responses, as it moves through clinical development. 

“The AVA6000 data in the clinic has led to a growing confidence in the pre|CISION™platform and its potential for patients. Our next generation programs will leverage the pre|CISION™platform as a foundation for other tumor-specific warhead delivery systems.

“This platform will underpin our wider clinical strategy and our ambition of bringing these novel cancer medicines closer to patients and delivering value for shareholders. Along with the rest of the team, I’m excited about the opportunity and look forward to expanding the opportunity that pre|CISION offers.”

Avacta will be hosting a live R&D Spotlight: Next Generation of pre|CISION™ Medicines in London on 30 October 2024. This event is open to both analysts and investors, further details are provided on the Company website at https://avacta.com/2024-rd-spotlight-live-event/.

  • Download the full interim results report here.