Advanced Oncotherapy Regulatory News (AVO)

PRIOR TO PUBLICATION, THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT WAS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION FOR THE PURPOSES OF REGULATION 11 OF THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS 2019/310. WITH THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

27 September 2022

ADVANCED ONCOTHERAPY PLC

("Advanced Oncotherapy" or the "Company")

Advanced Oncotherapy's LIGHT accelerator fully operational, achieving a 230 MeV beam

Significant milestone validates and de-risks the Company's first commercial LIGHT machine

University Hospitals Birmingham NHS Foundation Trust, the Company's clinical partner for this LIGHT machine, will now commission the treatment room following a pathway common in the proton therapy industry

First patient anticipated to be treated in H2 2023

LIGHT system expected to play a key role in 'democratising' the proton therapy market and addressing a significant unmet need

Advanced Oncotherapy (AIM:AVO), the developer of LIGHT, the next-generation proton therapy system for cancer treatment, is pleased to announce that its LIGHT1 accelerator has successfully generated a proton beam at 230 megaelectron volts ("MeV"), the energy required to treat deep-seated tumours at a depth of 32cm, at its assembly site in Daresbury, Cheshire, UK.

LIGHT is the first linear proton therapy system dedicated to the treatment of tumours where the proton beam is generated using linear acceleration, as opposed to traditional proton therapy systems which use a cyclotron to generate the beam. This is the most significant milestone in the Company's history and represents the work undertaken by Advanced Oncotherapy in a variety of complex scientific disciplines (including but not limited to the fields of physics, engineering and medicine) resulting in the development of a novel proton therapy system. The Company believes that the LIGHT system's small size and other unique characteristics (as outlined in the Note to Editors below) will make the treatment modality more accessible and affordable ('democratising') to cancer patients around the world whose tumours have been shown to respond to this therapy.

The Company's clinical partner, University Hospitals Birmingham NHS Foundation Trust ("UHB"), will now begin the commissioning process for the treatment room, with the aim of treating the first patient in the second half of 2023 at the assembly site in Daresbury. This will use a pathway followed by all proton therapy systems as part of the certification process.

Upcoming development milestones to be achieved in collaboration with UHB include:

(i) patient positioning and imaging system calibration;

(ii) approval of the patient treatment room in Daresbury in accordance with UHB guidance and requirements;

(iii) UK Health Research Authority ethical approval; and

(iv) end-to-end clinical test acceptance.

Together with UHB and Clarivate, a global analytics company, the Company continues to define the clinical protocol for treating the first patients with the LIGHT system. This has been conducted in close co-ordination with the US Food and Drug Administration ("FDA"), the UK Medicines and Healthcare products Regulatory Agency ("MHRA") and the European Notified Body, which the Company consults with on a regular basis.

The Company believes the LIGHT machine represents a lower cost option for the provision of proton therapy, making it more widely available to patients that need it. There are currently 114 proton beam therapy centres globally, meaning that only an estimated 87,000 cancer patients can be treated in a year, at a cost that is often out of reach of individual patients and unsustainable for healthcare systems. The Company believes that in the next twenty years the industry will need more than 10,000 additional proton therapy treatment rooms to be constructed to meet global demand, representing a 50-fold increase over the current global capacity.

Advanced Oncotherapy continues to progress its commercial pipeline and is exploring additional opportunities for the sale or lease of LIGHT machines to healthcare providers to aid in this significant unmet need. Ongoing work to optimise the Company's machine installation process following completion of the first operational LIGHT machine is anticipated to reduce manufacturing timelines for future LIGHT systems. The Company has already established partnerships with key customers including the London Clinic, Saba Partners and the Mediterranean Hospital in Cyprus, and, in addition to advancing these established partnerships, the Company anticipates today's validation of the LIGHT system to prompt further commercial momentum.

The Company intends to hold an investor day in October and further details will be provided in due course.

Dr. Michael Sinclair, Executive Chairman of Advanced Oncotherapy, said:

"We are excited to announce that our first LIGHT accelerator is now fully operational with a 230 MeV beam - a significant milestone in the Company's history, which marks the start of a new era for Advanced Oncotherapy and potentially the proton therapy market more broadly. There is currently a significant unmet medical need in the treatment of cancer and with this latest achievement we are a step closer towards achieving our mission of democratising proton therapy.

"We are hopeful that today's validation of the LIGHT system will prompt further commercial momentum and anticipate this to accelerate the execution of our commercial pipeline, and we look forward to providing further updates on this in due course. We look forward to moving towards the next stage of this project which will be led by our clinical partner UHB and use a pathway followed by all proton therapy systems as part of the certification process.

"On behalf of the Board, I would like to thank all our employees, suppliers and partners involved in this revolutionary project for their efforts and dedication towards the completion of our first machine. In addition, I would like to thank all our shareholders for supporting us and for their loyalty over the years."

Professor Steve Myers, Executive Chairman of ADAM S.A., added:

"After 20 years of research at CERN and ADAM, I am delighted to witness the application of this technology into the first commercial LIGHT machine operating at 230 MeV, a milestone which demonstrates that our unique technology works, and we are now keen to progress with our aim of making proton therapy available for many more patients."

- ENDS -

Notes to Editors

1 Linac Image Guided Hadron Technology

Background on the LIGHT system

LIGHT is a high frequency full-linear proton accelerator, developed by Advanced Oncotherapy, based on pioneering science from the European Organization for Nuclear Research ("CERN") and Applications of Detector and Accelerators to Medicine ("ADAM S.A.") in Switzerland.

The LIGHT system offers several advantages in comparison to circular proton therapy systems. Instead of accelerating protons in a spiral as is the case with cyclotrons, LIGHT speeds up the protons in a straight line. Protons are accelerated in a series of accelerating modules that can be individually switched on or off, a purely electronic process that is designed to be carried out at up to 200 times a second. The energy setting - relevant for determining the depth at which radiation is deposited - is achieved without the need to use mechanical absorbers, a major source of stray radiation that must be contained through large and expensive shielding. In addition, the LIGHT system allows for an ultra-fast delivery of radiation into tumours, which is 100-fold quicker than competing systems. The operational accelerator has been designed to continuously vary the energy levels of the proton beam, from 70 MeV to 230 MeV, in only five milliseconds.

Advanced Oncotherapy's LIGHT system is significantly smaller than traditional cyclotron-based proton therapy machines and its versatility and technical properties are expected to have a major impact on the proton therapy market, both in terms of clinical efficacy and affordability. LIGHT has been designed to minimise the costs of setting up and running a proton therapy centre, as it is modular and can be easily installed directly into clinical facilities. The modularity of the LIGHT system also brings additional benefits for customers in the context of facilitating high-volume production and optimising future costs as well as funding the acquisition of the equipment and reducing the upfront capital requirements.

About Advanced Oncotherapy Plc

Advanced Oncotherapy, a UK headquartered company with offices in London, Geneva, The Netherlands and in the USA, is a provider of particle therapy with protons that harnesses the best in modern technology. Advanced Oncotherapy's team "ADAM," based in Geneva, focuses on the development of a proprietary proton accelerator called, Linac Image Guided Hadron Technology (LIGHT). LIGHT's compact configuration delivers proton beams in a way that facilitates greater precision and electronic control.

Advanced Oncotherapy will offer healthcare providers affordable systems that will enable them to treat cancer with innovative technology as well as expected lower treatment-related side effects.

Advanced Oncotherapy continually monitors the market for any emerging improvements in delivering proton therapy and actively seeks working relationships with providers of these innovative technologies. Through these relationships, the Company will remain the prime provider of an innovative and cost-effective system for particle therapy with protons.