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.

30 June 2022

ADVANCED ONCOTHERAPY PLC

("Advanced Oncotherapy" or the "Company")

Final results for the year ended 31 December 2021

Significant progress made towards completing a fully operational LIGHT system with a 230MeV beam; RF conditioning of all CCL accelerating modules completed

Company continues to expect a fully operational LIGHT system at 230 MeV during summer 2022

Further research published highlights the potential superiority of the LIGHT system

Advanced Oncotherapy (AIM:AVO), the developer of LIGHT, the next-generation proton therapy system for cancer treatment, today announces its audited results for the year ended 31 December 2021.

Key Highlights (including post-period):

· Significant progress made towards completing the Company's first fully operational LIGHT system operating at 230 MeV:

o  Completed manufacturing of all critical hardware of the LIGHT system and all CCL accelerating modules have been radio-frequency ("RF") conditioned.

o  The machine beam has been successfully optimised to a sub-millimetre size and is capable of supporting a proton beam pulse every 5 milliseconds.

o  Fully integrated medical software suite is now in place, the construction of the medical treatment room has been completed, and the LIGHT Patient Positioning System has been installed, providing future customers with a seamless user experience.

o  Good progress has been made in preparing data to be sent to the US Food and Drug Administration (FDA) regarding the stability, intensity and spot size of the proton beam.

o  Optimised the installation process to enable quicker set-up of future LIGHT systems.

· Continue to expect a fully operational LIGHT system operating at 230 MeV during summer 2022, despite the impact of the COVID-19 pandemic.

· Signed a lessor financing partnership with Kineo Finance which will provide potential customers with easier access to the Company's LIGHT system by reducing the need for large initial upfront payments.

· Signed a letter of intent (LOI) with Saba Partners SA for the proposed purchase of a three-treatment room LIGHT system in Switzerland.

· A number of recently published research papers and conference presentations highlight the potential superiority of the LIGHT system to deliver FLASH, further differentiating the machine from cyclotron-based proton therapy systems.

· During the period and post period raised c.£58 million (before costs) through equity fundraises which strengthened the Company's balance sheet and contributed to the funding for progressing the assembly, documentation, verification and validation activities.

Nicolas Serandour, CEO of Advanced Oncotherapy, said:

"Over the past 12 months, the Company has made significant strides towards the delivery of its first fully operational LIGHT system operating at 230MeV. We finished manufacturing all critical hardware of the LIGHT system and RF conditioned all CCL accelerating modules. The LIGHT machine's beam has been successfully optimised to a sub-millimetre size and the machine is capable of supporting a proton beam pulse every 5 milliseconds.

"As a result of our efforts, we have further developed our knowledge and streamlined our processes, which will accelerate the development of future machines and, in turn, set the foundations to fast forward the global adoption of the LIGHT system.

"I am looking forward to the year ahead, as 2022 will be a significant year in the history of Advanced Oncotherapy, as we remain on track to deliver a fully operational LIGHT system operating at 230MeV this summer. Recent progress and successes would have not been possible without the outstanding work and dedication of our staff and the continuous support from our shareholders. We believe the Company is now positioned to deliver on our vision of helping to defeat cancer and democratise proton therapy across the globe."

Posting of Annual Report and Notice of Annual General Meeting

The annual report for the year ended 31 December 2021, which includes notes to the financial statements, will be available shortly from the Company's website at www.advancedoncotherapy.com and will shortly be posted or emailed to shareholders together with a Notice of Annual General Meeting to be held at the Company's administrative head office at Level 3, 4 Tenterden Street, London W1S 1TE on Friday, 29 July 2022 at 2.00pm BST.

Notes

The following section outlines some of the key technical components for the LIGHT system (referred to in today's announcement)

· Coupled cavity linacs (CCLs) - The CCL structures or "higher speed accelerators" are an essential part of the LIGHT Accelerator. They consist of a series of "cells" which accelerate the protons from 37.5 MeV to energies that can be applied usefully to a clinical setting (70 MeV to 230 MeV).

· RF conditioning - The radio-frequency ("RF") conditioning involves gradually increasing the input power until there is an electrical "breakdown". After each breakdown, the accelerating modules can sustain an increase in the input power. This process is continued and iterative until the power reached is 20% above the nominal values. This ensures great stability when operating at nominal power. As the Daresbury LIGHT system is expected to be the first linear proton accelerator to be commissioned for medical use, the RF conditioning is unprecedented, hence carrying some level of uncertainty with regards to the time needed to complete this important task. This risk has been significantly removed following recent progress.

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.

STATEMENT FROM EXECUTIVE CHAIRMAN AND CHIEF EXECUTIVE OFFICER

Dear shareholders,

Despite the unknowns brought by COVID-19 over the period, the Company's objectives and purpose remained consistent with our vision of democratising proton therapy and guided our employees and partners to overcome moments that, at times, seemed insurmountable. We are now pleased and proud to say that Advanced Oncotherapy is on the verge of doing something that has never been done before - building a sustainable and value-enhancing platform to democratise access to proton therapy. We continue to be centre stage in the transformation of cancer care and the deployment of proton therapy, and what we do in this critical phase will define us for decades.

From C to Sea

Over 20 years ago, when family members had cancer, they would often call it the C word and it was hard to blame them: cancer was largely a death sentence for those who were unfortunate enough to get it. Few people can say their lives have not been touched by the disease, either personally or through friends and family. However, the combination of advances in cancer treatments, improved awareness and diagnosis, has changed the trajectory and prognosis of cancer.

Cancer mortality rates have plummeted over the past years, with four out of five of those diagnosed with childhood cancer set to survive for more than five years after diagnosis. While this is great news, much more remains to be done. An estimated ten million people die from cancer each year, and about 75% of cancer survivors have one or more health problems, often as a side-effect of the treatments they received, ranging from heart failure due to chemotherapy, to secondary malignancies as a result of radiotherapy. Chronic problems are also associated with surgeries to remove cancers. These methods have influenced an 'innovation' mindset that is focused on improving clinical outcomes and patients' quality of life. This is best exemplified by the development of more targeted cancer modalities, arguably the most important paradigm treatment shift in cancer care over the last decade.

Proton therapy - as an effective proven radiation therapy with limited long-term side effects due to its high precision - has a key role to play in transforming cancer treatment. Yet, with only 114 proton therapy centres currently across the globe, only circa 87,000 cancer patients can be treated in one year at a cost which is often out of the reach of individual patients and is clearly unsustainable for healthcare systems. This situation is unsatisfactory and, as such, access to proton therapy needs to be democratised. We believe this can be achieved through our 'blue ocean' strategy which relies on the following '5S' principles:

· Solving customers' needs: Our LIGHT solution consists of a breakthrough linear accelerator, an integrated imaging and positioning system and the latest software advancement, which when taken together provide a medically superior solution that is easier to install and can be fitted in existing structures, and more accessible, resulting in a significantly lower treatment cost for payors. This is not only value-enhancing for our customers, but also for the Company's shareholders;

· Supporting customers through long-term servicing agreements;

· Scaling our infrastructure to deliver a fast-growing pipeline, further reduce costs and lead times;

· Sharing our vision with all stakeholders through a long-term interest alignment. We intend to expand the market opportunity through a uniquely designed business model built upon a joint risk / reward sharing policy as evidenced by the profit-sharing arrangements agreed with customers; and

· Sustaining our competitive advantage by leveraging our proprietary LIGHT platform through a continuous commitment to innovate, attracting top talent and making a positive impact on wider society and the environment.

We expect our '5S' strategy to break out the conventional barriers that currently define the radiation market.

Executing our global strategy

In a highly regulated industry, we must continue to demonstrate our ability to adapt to our environment and remain agile by accelerating the speed at which we execute our strategy to deliver improved returns. In 2021, the executive team made significant progress in overseeing the assembly of the LIGHT system at our assembly and integration site located in Daresbury, UK, as well as laying out the groundwork for a potential successful market approval.

Execution of our '5S' strategy has also required a disciplined approach to how we invest in our assets. Over the last two years, we have made significant investments in our infrastructure. The trajectory of investment across our organisation is pivoting towards further cost optimisation for future machines and faster delivery times. The Board supports this approach and continues to encourage the executive team to shift their attention to rapid execution, with the key focus areas being the long-term financial benefits of making Advanced Oncotherapy the undisputed industry leader and innovator in the proton therapy field. This is crucial if we are to benefit from the versatility of the LIGHT platform and knowledge uniquely nurtured within our organisation as we pursue our various multi-year strategic goals.

In 2021, our execution plan and resilience as an organisation continued to be tested by COVID-19. While the pandemic has resulted in continual shifts and disruptions to normal business patterns - supply chain functioning, fluctuating demand in certain areas, workplace operations - we continued to be focused on our LIGHT project. We instigated supply chain initiatives to identify and use alternative components and suppliers whilst complying to ISO standards and medical device requirements. We contracted with key suppliers to recruit additional installation and testing expertise and capacity. Most importantly, we kept our sights on our long-term objectives and our dynamic vision for the future of health. This confirmed the fortitude of our employees and dedication to the values that guide our behaviour every day and help us to build a business of the future. We are inspired by the abundant accounts of the extraordinary care, compassion and commitment of our employees as well as the strength of our organisation which has been resourceful and adaptable, able to anticipate, improvise, and draw on deep reserves of experience, relationships, and know-how.

The LIGHT system: a machine that will revolutionise cancer treatment

There is currently a significant unmet medical need in the treatment of cancer, and we believe the LIGHT system can play a key role in revolutionising cancer therapy. The modularity and movability of the LIGHT system allow us to lease machines to healthcare providers - a new business model in the proton therapy market - uniquely positioning the Company in the market and providing us the opportunity to play a key role in revolutionising proton therapy.

The accelerator, currently under final assembly, is driven by four inductive output tubes (IOTs) operating at 750 MHz, which generate the relevant power for the radiofrequency quadrupole (RFQ), and 13 klystrons operating at 3 GHz, which provide high radio-frequency power to the machine to accelerate the proton beam. The accelerator is cooled, kept under vacuum, and monitored by beam diagnostics and the Company's time-of-flight energy measurement algorithm. Our proprietary LIGHT Accelerator Control System integrates more than 300 separate devices and is driven from a control room where operators accelerate and steer the proton beam. Protons go through a gallery of accelerators moving as a 200Hz pulsed beam through the RFQ, the side-couple drift tube linacs (SCDTLs) and then through the 15 coupled cavity linacs (CCLs) accelerating up to a maximum energy of 230 MeV, the energy required to treat deep-seated tumours at a depth of 32cm. Patient treatment will take place in the treatment room which is located at the end of the accelerator where a state-of- the-art robot chair, with CT scanner and X-Ray panels for accurate patient positioning, has been installed.

During the period, the Company has continued to make significant progress with the commissioning of the LIGHT system. The machine installed at Daresbury has been successfully optimised to deliver a proton beam with a beam size smaller than 1 mm and a beam current of about 50 μA, equivalent to 500 million protons per pulse. As a result, the Company has made good progress in preparing data for the US Food and Drug Administration (FDA) regarding the stability, intensity and spot size of the proton beam. These new data sets demonstrate that the measurements of the quality of the beam match those from computer simulations. The Company can now proceed to finalise the integration of the remaining high energy accelerating modules of the LIGHT machine and further optimise the proton beam.

We have continued to work with our clinical collaborator (the University Hospitals Birmingham NHS Foundation Trust) and Clarivate, a global analytics company, to define the clinical protocol for treating the first patients. These discussions have been held in close coordination with the FDA, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Notified Body, which we consult with on a regular basis. As a result of these discussions, the Company has been requested to provide new measurement data to confirm that the beam performance is maintained within the required tolerances for the clinical use both in terms of energy (i.e. depth in the body) and intensity (i.e. number of protons per second). Although these measurements have not been conducted with the final configuration for 230MeV, they indicate that the beam stability is not a cause for concern in the planned final configuration, a key step which is expected to de-risk the overall certification process. This request originates from the fact that the key LIGHT components are now assembled in situ at Daresbury and the underlying parameters have been optimised in recent months as the Company performs the verification and validation activities, a key step in ensuring product certification.

Commercial momentum

Over the past year, we continued to build commercial momentum around the LIGHT system. During the period, we signed a lessor financing partnership with Kineo Finance (formerly known as DiaMedCare). Under the terms of the partnership agreement, Kineo Finance will acquire LIGHT systems from the Company and lease them to customers that are commissioning the LIGHT system for oncology treatments. As such, we will be able to offer customers easier access to the LIGHT system through a flexible financing solution that reduces the need for large initial upfront payments from customers.

During the period, we also signed a letter of intent with Saba Partners SA for the proposed purchase of a three-treatment room LIGHT system in Switzerland. The Company is working to obtain the applicable CE marking clearances and is working with Saba Partners to put in place a binding agreement and finalise the legal documentation. These agreements build on the commercial momentum for the LIGHT system from our earlier agreements with the London Clinic, the Mediterranean Hospital in Limassol, Cyprus, and University Hospital Birmingham NHS Foundation Trust (UHB).

Adapting our structure to address health, social and environmental challenges

Our long-standing aspiration of creating value for society and for our future business is more relevant than ever, given the mounting threats to people's lives and livelihoods posed by the health, social and environmental challenges dominating today's global agenda. The past two years have underscored the essential role of science in tackling these challenges, whether managing a rogue virus or transitioning into an eco-friendlier environment.

In that regard, we are committed to being a sustainable business. To achieve this ambition, we strive to do business in a financially, environmentally, and socially responsible way. We have designed a breakthrough proton system that is well-positioned to meet the increasing needs of our customers and patients who are demanding more circular and sustainable products around the world. We have a clear, science-based, disciplined and affordable path to further promote our ESG principles; which is particularly relevant as we continue to grow our capacity.

Furthermore, we are committed to strong diversity through ensuring academic qualifications are not the sole criteria for hiring, bespoke training and mentoring, flexible working policies and an inclusive culture as well as having the right competences to meet future challenges.

Financing foundations

We have been able to continue with progressing our activities as a result of the completion of equity investments since January 2021 totalling c.£58 million (before costs). Funds raised have supported the Company as it progresses towards having a fully operational LIGHT system operating at 230MeV during summer 2022.

Our financial results

The Company recorded a comprehensive loss of £30.3 million in the year ended 31 December 2021 (2020: £23.4 million), with shareholder funds as at 31 December 2021 of £61.4 million (2020: £44.1 million). Cash and cash equivalents at the year-end were £4,260,490 (2020: £2,317,451).

Outlook

Looking ahead, 2022 is a significant year for us at Advanced Oncotherapy as we move towards the delivery of our first LIGHT system operating at 230 MeV. We have made significant strides towards achieving this milestone during the period and have set the foundations to fast forward the global adoption of the LIGHT system. We remain on track with our timeline of summer 2022 to deliver a machine at 230 MeV.

In closing

The Company has emerged stronger despite the challenges it faced in 2021. We have made significant progress towards the delivery of our first LIGHT system operating at 230 MeV and have shown resilience in the face of adversity. We are convinced that this Company is taking the right steps to shape a successful future.

Such progress would not have been possible without the tremendous effort and dedication of our staff. We remain confident in our ability to deliver the first machine with a 230 MeV beam during summer 2022 and look forward to what will continue to be a significant year for the Company.

On behalf of the Board of Directors, we would like to offer our sincere thanks to all Advanced Oncotherapy employees for their dedication and contributions to the good operational and strategic progress and to the management team for their leadership. And most importantly, thank you for supporting us as shareholders, for your loyalty and for being a part of our journey.

1. GENERAL INFORMATION

Advanced Oncotherapy PLC ("the Company") is a public limited company incorporated and domiciled in the UK. Its registered office is Level 17, Dashwood House, 69 Old Broad Street, London EC2M 1QS.

The nature of the operations and principal activities of the Company and its subsidiary undertakings (the "Group") is to provide particle therapy with protons that harnesses the best in modern technology

The Company's ordinary shares are traded on the AIM market of the London Stock Exchange ("AIM").

2. BASIS OF PREPARATION

The financial information set out in this announcement does not constitute statutory accounts as defined by section 435 of the Companies Act 2006. It has been prepared in accordance with the prepared in accordance with the recognition and measurement principles of international accounting standards in conformity with the requirements of the Companies Act 2006 and in accordance with the AIM rules and is therefore not in full compliance with IFRS. The financial information has been prepared on the historical cost basis modified to include certain assets and liabilities at fair value.

The financial information is based on the financial statements for the year ended 31 December 2021 which are authorised for issue. The audit report will not be modified but does include a material uncertainty in respect of going concern. It does not contain a statement under 498(2) or 498(3) of the Companies Act 2006.

The Group has made a loss before tax of £29.5m (2021: £23.4m) and is presently pre-revenue and, as such, has relied upon equity and debt funding to progress its development plans. Post year end, the Group has successfully raised £11.5m in equity and £1.5m in short term loans.

The Directors regularly review cash flow forecasts to determine whether the Group has sufficient cash reserves to meet its future working capital requirements and development plans. The Group's plans indicate that they need to raise further finance and the Directors are confident based on past history of successful fundraising and discussions with investors that the Group will be successful in raising these funds. Additionally, they consider they can defer settlement of creditors, reduce short term expenditure and obtain short-term finance should there be any delay in completing any such fundraising to allow continuance of their plans. They therefore consider it appropriate to prepare the Group's financial statements on a going concern basis.

However, as at the date of approval of these financial statements, there are no legally binding agreements in place in relation to any fundraising or extension of terms of with creditors and as the success of any finance raising is outside the control of the company and is thus considered to be a material uncertainty. There can be no certainty that additional funds will be forthcoming which indicates the existence of a material uncertainty which may cast doubt about the Group's ability to continue as a going concern and therefore it may be unable to realise its assets and discharge its liabilities in the normal course of business. The financial statements do not include the adjustments that would result if the Group was unable to continue as a going concern.

3. POST BALANCE SHEET EVENTS

Since the year end, the Group has raised additional equity through the issue of shares:

On 23 March 2022, the Company entered into a new short term loan agreement of £1.5 million with Nerano Pharma Ltd, a company owned and controlled by Seamus Mulligan, a significant shareholder in the Company, with an interest rate of 1.25 per cent per month (the "Loan"). The Loan is repayable by the Company on 24 June 2022. As part of the agreement, the Company issued 6,382,978 warrants to Nerano Pharma Ltd with an exercise price of 28.20 pence per share, exercisable until 24 March 2025.

As at the date of publication of this report, the Loan remains outstanding. Nerano Pharma has agreed not to seek repayment at the current time and is in discussions with the Company surrounding the potential to convert the Loan into New Ordinary Shares. At the current time no agreement has been entered into in relation to varying the terms of the Loan nor have the terms of any variation been, as yet, agreed. In the event that the terms cannot be agreed between Nerano Pharma and the Company, the Company would seek to repay the amounts owed pursuant to the Loan.