Tag: AVO

  • Advanced Oncotherapy expected to disrupt the market says Hardman & Co (LON:AVO)

    Advanced Oncotherapy expected to disrupt the market says Hardman & Co (LON:AVO)

    Advanced Oncotherapy plc (LON:AVO) is the topic of conversation when Hardman and Co’s Head of Life Sciences Dr Martin Hall caught up with DirectorsTalk for an exclusive interview.

    Q1: You recently released a report on Advanced Oncotherapy highlighting some recent developments at the company. Can you update us what has been going on?

    A1: To set the scene, Advanced Oncotherapy or AVO, was established with the goal to develop a proton therapy system to treat cancer patients that was affordable, thereby making proton therapy more universally available.

    Until September 2022, the focus of the company’s activities has been on the technical aspects and potential advantages of its new system, which is called LIGHT. Then it announced that it had completed the complex assembly of its linear accelerator, involving over 34,000 components, and demonstrated that it could accelerate a proton beam to an energy level of 230MeV, the level required to reach and treat the most deep-seated organs in the human body. This was a major breakthrough and something that many industry commentators, particularly the established competitors, thought would never happen. It has also moved the risk from a high technology risk to a much lower execution risk.

    Q2: Given this major breakthrough, why are the share languishing?

    A2: I believe that there are three main reasons.

    First, despite achieving this important milestone, there are still a number of ethical and regulatory procedures that must be completed before first patient treatments and, while there is nothing overly complex, they all take time. So, first patients are expected to be treated in 2H’23, a little later than originally planned.

    Secondly, in 2022, Rutherford Health an operator of three proton therapy centres in the UK went into administration, because it was not seeing a sufficient throughput of patients to generate a return. Some commentators are fearful that AVO will suffer the same fate. However, the businesses are completely different. Rutherford built and operated facilities, whereas AVO is a manufacturer of proton therapy equipment and systems. Rutherford adopted a one-system-one-treatment room model, limiting patient throughput, whereas one LIGHT machine can potentially be used in up to five treatment rooms, maximising throughput for its customers. Finally on this point, Rutherford was UK-centric, whereas AVO intends to install LIGHT globally, particularly in the big opportunities in the US and China.

    Thirdly, AVO still needs more capital, confirmed yesterday to be around £75m which compares with our forecast of £70m, for working capital over the next two years in order reach first-patient treatments, regulatory approvals and commercialisation. The market has known this and, in such situations, tends to mark shares down in the hope of buying as cheaply as possible in an institutional placing.

    Q3: Given what you have said about Rutherford, is there really enough demand?

    A3: Cancer remains an enormous global burden and is responsible for many deaths each year. Radiation is still the mainstay of cancer therapy, but X-rays are very imprecise and cause damage along their pathway and to surrounding healthy tissue. Proton therapy is very precise and causes damage in a pin-point manner to cancerous tissue.

    But, despite these advantages, worldwide, there are only just over 100 proton therapy centres with 260 treatment rooms, and less than 1% of cancer patients receive this type of treatment annually. It is estimated that nearer 2,000 centres with 4,800 treatment rooms are required just to treat 10% of cancer patients, so the potential demand is staggering.

    Q4: Why do you think LIGHT will be successful?

    A4: The key reason why there are so few proton therapy centres worldwide is the cost. Apart from the equipment cost, there is also a massive capital outlay on the building itself which needs to be bespoke. For example, the new centre at University College Hospital London, cost £209m to construct excluding the cost of the PT equipment and has taken six years to build. This is prohibitive in the absence of government support.

    We expect LIGHT to be successful because of the process by which it generates the proton beam to the required energy level to treat the cancer. Conventional cyclotrons generate a proton beam to a single high energy. This is then reduced to the working level through the use of absorbers or filters, with the excess radiation being wasted. This is very inefficient, expensive and potentially dangerous to the patients and operators, so they require considerable lead shielding. In contrast, LIGHT accelerates the protons only to the required energy level, meaning that there is minimal wastage and significantly fewer protective measures are needed. This is far more efficient and requires a much smaller footprint, significantly lowering construction costs.

    Secondly, LIGHT is modular in design, making it possible to be retrofitted into an existing building, which is what will be done at the Harley Street facility. This also simplifies the manufacturing and installation process which, as experience and volumes increase, is expected to take only one year from signature. Consequently, both facility and equipment costs are expected to be much lower with LIGHT, making PT much more affordable. Additionally, being modular, alternative business models can be adopted, whereby the LIGHT system can be owned by a financial group and leased to the hospital or clinic with returns on a pay-per-patient basis. This is not possible with conventional systems.

    Finally, LIGHT is really well suited to new treatment techniques, such as FLASH, where the treatment is split into multiple electronically controlled small fractions of the dose required, potentially reducing treatment down to a single visit, compared with 20+ visits needed currently. While cyclotron manufacturers are trying to adapt to these new techniques, their overall inefficient process is not conducive to FLASH technology.

    Q5: What do you think of the valuation?

    A5: As you can glean from everything that has been said, there are massive barriers to entry. However, although it has taken longer than planned, AVO is almost there and is expected to disrupt the market. To get where it is today, AVO has invested about £215m. However, based on today’s share price, the company is trading at a 42% discount to the amount invested. This is clearly reflecting the need for more capital, about which the company is investigating all avenues, both dilutive and non-dilutive.

    We expect to see further announcements of commercial deals in 2023, particularly after the first patients have been treated. This is when orders and delivery schedules are confirmed and deposits are paid, substantially changing the cashflows. On our revised model, details of which are in our report, AVO is forecast to become EBITDA breakeven in 2025. This should help it to raise the required capital.

    Also, thinking laterally, the incumbent main players must be concerned about LIGHT’s disruptive technology and even though the demand is large enough to accommodate a new entrant and for everyone to still be successful, they must be concerned.

    Consequently, if AVO’s valuation does not re-rate soon, there is potential for M&A activity, especially given that Siemens Healthineers paid $16.4bn for Varian last year to gain more access to the cancer markets and proton therapy, in particular. Compared with, that Advanced Oncotherapy must look very attractive.

  • Advanced Oncotherapy Current EV significantly below cumulative investment to date (VIDEO)

    Advanced Oncotherapy Current EV significantly below cumulative investment to date (VIDEO)

    Advanced Oncotherapy (LON:AVO) is the topic of conversation when Dr Martin Hall, Analyst at Hardman & Co joins DirectorsTalk.

    Martin updates us on some of the recent developments at the company, explains why the share price is languishing, the demand for the project, shares his thoughts on the success of LIGHT and the company valuation.

    Advanced Oncotherapy plc is a UK-based company focused on delivering a cost-effective proton-based radiotherapy solution called LIGHT. Based on ground-breaking technology developed and tested at world renowned CERN in Switzerland, the LIGHT system delivers an integrated proton radiotherapy system to treat cancer.

  • Advanced Oncotherapy: Understanding the significance of 230MeV

    Advanced Oncotherapy: Understanding the significance of 230MeV

    Advanced Oncotherapy plc (LON:AVO) goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology, developed originally at the world-renowned CERN. The complex assembly of the first LIGHT accelerator in Daresbury (UK) has been completed and demonstrated to generate a full-energy proton beam (230MeV) required to treat deep-seated tumours. AVO is now liaising with its clinical partner, University Hospitals Birmingham (UHB) NHS Foundation Trust, to prepare for first-patient treatments in 2H’23. Following this significant project de-risking, our updated LIGHT model shows that AVO could become EBITDA-positive in 2025.

    • Strategy: Advanced Oncotherapy is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and supported by a world-class supplier base.
    • 230MeV: LIGHT is the first linear accelerator capable of generating a high- energy (230MeV) proton beam – a major milestone that greatly de-risked the project. The technical and clinical advantages of LIGHT are increasingly apparent to prospective customers, as AVO approaches first-patient treatments in 2H’23.
    • Updated model: Our revised LIGHT model has been simplified by assuming that AVO takes only a minority stake in partnership projects where customers adopt the alternative financing approach; so financials are not consolidated. On this basis, AVO looks set to become EBITDA-positive during fiscal 2025.
    • Risks: More capital will be required until first-patient treatments in 2H’23. Having hit the 230MeV milestone, competitors with legacy cyclotrons are likely to take an aggressive commercial stance to protect positions. Many of the high-quality modules use copper, the price of which is sensitive to global economics.
    • Investment summary: Despite hitting the revolutionary milestone, the shares have languished probably because of the time needed until first-patient treatments and an incorrect read-across to Advanced Oncotherapy by the demise of Rutherford Health (Rutherford). The current EV represents a 42% discount to the investment made into the project to date. Our updated model suggests that AVO will become EBITDA-positive in fiscal 2025 and that the NPV of the DCF model is now 156p on a fully-diluted basis.

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  • Advanced Oncotherapy: Major milestone achieved

    Advanced Oncotherapy: Major milestone achieved

    Advanced Oncotherapy plc (LON:AVO) goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology, developed originally at the world-renowned CERN. The complex assembly of its first LIGHT accelerator in Daresbury has been completed and demonstrated to generate a full-energy proton beam (230MeV) required to treat deep-seated tumours. AVO is now working with its clinical partner, University Hospitals Birmingham NHS Foundation Trust (UHB), to commission the treatment room and prepare for regulatory certification. This significant de-risking of the project paves the way for further commercial deals.

    • Strategy: Advanced Oncotherapy is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and relies on a world-class supplier base.
    • Key milestone: AVO has been assembling its first full-energy LIGHT system at Daresbury, piecing together about 1,500 components. It has successfully accelerated the proton beam to 230MeV for treating deep-seated tumours, a major milestone that significantly de-risks the project.
    • Next steps: AVO’s clinical partner, UHB, will now begin commissioning the treatment room and continue to define the protocol that will be used to treat first patients in 2H’23. Also, AVO is working with UHB to co-ordinate some of the US and EU regulatory processes in order to get formal certification of LIGHT.
    • Risks: The commissioning and validation process for treating patients is important and well-established, but it can also be laborious, and much of it is outside the control of AVO.
    • Investment summary: After some years in development, Advanced Oncotherapy is close to the finishing line with its first fully operational LIGHT system accelerator. The goal is to have a pipeline of installations to satisfy the pent-up demand and bring down the cost of PT. This announcement represents a major milestone and significantly de-risks the whole project, and provides comfort to potential customers regarding deliverability. Consequently, it paves the way to signing more commercial deals

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  • Advanced Oncotherapy: LIGHT – regulatory update

    Advanced Oncotherapy: LIGHT – regulatory update

    Advanced Oncotherapy plc (LON:AVO) goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology developed originally at the world-renowned CERN. The company is in the process of completing the complex assembly of its first full energy system, optimising, validating and verifying all aspects of this process. Meanwhile, it is liaising with the relevant regulators as part of the approval process. The FDA has requested some specific beam measurement data, which has added three months to the process but will generate important technical data that differentiates LIGHT and could be used in future marketing.

    • Strategy: Advanced Oncotherapy is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and relies on a world-class supplier base.
    • Regulatory update: Although the FDA has requested some specific proton beam measurement data that will add up to a maximum of three months to the completion schedule, it highlights the progress that AVO has made with the FDA, and US regulatory approval now appears likely to come ahead of CE marking.
    • First LIGHT: Having been developing this highly technical and complex project for the past six years, the FDA’s request for additional data suggests that the first fully energy LIGHT system will now be completed by the end of 2Q’22. However, the market should be comforted by the progress made towards US approval.
    • Risks: To date, one of the key risks has been funding. However, AVO’s recent largest capital increase, coupled with alternative financing arrangements, have greatly diminished this risk. Regulatory risks have been reduced through ongoing dialogue with the FDA via the modular Q-Submission 510(k) process.
    • Investment summary: After some years in development Advanced Oncotherapy is nearing the finishing line with its first LIGHT system. However, the goal is to have a pipeline of installations to satisfy the pent-up demand and bring down the cost of PT. The current EV is lower than the quantum of investment to get LIGHT to where it is today. Additionally, the NPV of the cashflows from all potential sources of income from AVO’s evolving business model is currently 215p (161p fully diluted).

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  • Advanced Oncotherapy: On the home straight

    Advanced Oncotherapy: On the home straight

    Advanced Oncotherapy plc (LON:AVO) goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology developed originally at the world-renowned CERN. Over the past two years, important technical milestones have significantly de-risked the project. Now, AVO is working on the verification and validation phase, prior to LIGHT being used on the first patients to support CE marking. At its recent investor day, the company highlighted how its differentiated business model is attracting commercial partners that should enhance long-term shareholder returns. Additionally, it is reducing the cost of PT so that it becomes accessible to all.

    • Strategy: AVO is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and relies on a world-class supplier base.
    • First LIGHT: Advanced Oncotherapy has been actively working towards its target of delivering the first LIGHT system by the end of 2021. While this goal is possible, certain external factors impacting the supply chain, such as the global shortage of semi-conductors and thermo-switches, could see this slip into 1Q’22.
    • Business model: Modularity of the LIGHT system offers more flexible financing options for customers in comparison to what is possible with traditional straight purchases of LIGHT: more specifically, large upfront capital outlays are not needed under an operating partnership business model. Our forecasts reflect a mix of traditional straight purchases and operating partnerships.
    • Risks: To date, one of the key risks has been funding. However, AVO’s recent largest capital increase, coupled with the alternative financing arrangements, have greatly diminished this risk. Timing for the first fully operational LIGHT system might be affected by external factors beyond the company’s control.
    • Investment summary: After some years in development, Advanced Oncotherapy is nearing the finishing line with its first LIGHT system. However, the goal is to have a pipeline of installations to satisfy the pent-up demand and bring down the cost of PT. The current EV reflects only the quantum of investment to get LIGHT to where it is today, whereas the NPV of the cashflows from all potential sources of income from AVO’s evolving business model is currently 217p (162p fully diluted).

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  • Advanced Oncotherapy: Leveraging the modularity of LIGHT

    Advanced Oncotherapy: Leveraging the modularity of LIGHT

    Advanced Oncotherapy plc (LON:AVO) goal is to deliver an affordable and novel PT system, called LIGHT, based on state-of-the-art technology developed originally at the world-renowned CERN. Over the past two years, important technical milestones have significantly de-risked the project. Now, AVO is working on the verification and validation phase, prior to LIGHT being used on the first patients to support CE marking. At its recent investor day, the company highlighted how its differentiated business model is attracting commercial partners that should enhance long-term shareholder returns. Additionally, it is reducing the cost of PT so that it becomes accessible to all.

    • Strategy: AVO is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and relies on a world-class supplier base.
    • PT therapy: Currently, PTCOG estimates that there are 240 treatment rooms available in 97 PT centres worldwide. However, the number of treatment rooms needed by 2040 is estimated to be 10,000, which implies 20% CAGR for the next 20 years. To achieve this, costs need to be significantly reduced.
    • Attractions of LIGHT: Conventional cyclotron accelerators need to be installed into the deep sub-basement early in the construction of a PT centre. In contrast, AVO’s LIGHT system, with its linear accelerator, can be assembled into a ready-built structure. Being modular, it can be used as security in a financing deal.
    • Novel business model: Unlike conventional models which rely solely on the initial equipment sale followed by long-term service and maintenance contracts, AVO is adopting a model that combines traditional sales with customer profit-sharing arrangements, and facilitates the roll-out of technology upgrades.
    • Investment summary: After some years in development, Advanced Oncotherapy is nearing the finishing line with its first LIGHT PT system. However, the corporate goal is to have a pipeline of installations to satisfy the pent-up demand and bring down the cost of PT, thereby making this form of treatment available to many patients. The current EV only reflects the quantum of investment to get LIGHT where it is today, whereas the NPV of the cashflows from all potential sources of income from its novel business model is 214p (178p fully diluted).

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  • Advanced Oncotherapy Analyst Q&A: Positioned well for CE certification application (LON:AVO)

    Advanced Oncotherapy Analyst Q&A: Positioned well for CE certification application (LON:AVO)

    Advanced Oncotherapy plc (LON:AVO) is the topic of conversation when Hardman and Co’s Analyst Dr Martin Hall caught up with DirectorsTalk for an exclusive interview.

    Q1: You recently released a report on Advanced Oncotherapy highlighting some recent developments at the company. Can you update us what has been going on?

    A1: As a reminder, AVO was established with the goal to develop a proton therapy system to treat cancer patients that was affordable, making it more universally available. Until now, the focus of the company’s activities has been on the technical aspects and potential advantages of its new proton therapy system, which is called LIGHT. During the first half of 2020, the company made a number of announcements about commercial partnerships, highlighting that the company is close to finishing its first LIGHT system and that potential purchasers are comfortable that LIGHT will be completed and validated in the near future.

    Q2: Can you tell us some more about the potential advantages of LIGHT?

    A2: Yes, I will separate them into three parts, but I will not go into the complex technical aspects.

    First, proton therapy is based on protons being accelerated to a very high energy level which can then be targeted precisely at areas of cancerous tissue. Conventional cyclotrons generate a proton beam with a single high energy which is reduced to a working level through the us or absorbers or filters, with the excess radiation being wasted. Consequently, to protect patients staff and external people, considerable lead shielding is required. In contrast, LIGHT accelerates the protons only to the required energy level, meaning that there is little wastage and the protective measures needed are much less.

    Secondly, and linked to that first point, clinics using conventional cyclotrons need to be large, purpose built facilities, which adds a significant additional cost to the project. In contrast, LIGHT is modular in design, making it compact and giving it flexibility in the construction process, thereby enabling it to be sited in smaller, often existing buildings. A good example of this is the Harley Street facility. Consequently, the construction costs are only a small percentage of those for a cyclotron.

    Thirdly, physicians are continually looking at new and advanced technologies that might boost therapy and improve patient outcomes. The LIGHT system is far more adaptable and, for example, can be used with new fractionation techniques to significantly reduce the number of times a patient needs to visit the clinic for treatment.

    Thirdly, and this was announced subsequent to our research report, AVO announced a collaboration with University Hospitals Birmingham NHS Foundation Trust for the construction and installation of a LIGHT system in Birmingham.

    Q3: So how close are we to the first LIGHT system?

    A3: The company highlighted in its interim results statement that all the key modules for a LIGHT system have been manufactured, validated, and delivered to its assembly site in Daresbury, Cheshire. These are currently being integrated. The patient positioning system is currently in transit.

    However, like most companies, AVO has not been immune to the consequences of Covid-19 and had to close Daresbury, temporarily, during the lockdown. Hand-in-hand with the assembly process, detailed documentation needs to be written as part of the regulatory process. So AVO took the opportunity provided during the lockdown to get all this paperwork advanced, together with an upgrade to the software for its treatment planning system. This has positioned AVO well for its application for CE certification.

    Q4: How is AVO funding all of this work?

    A4: Financing a technically complex medical device project is capital-intensive and has been a challenge in difficult markets. However, given the significant technical progress and considerable de-risking of the LIGHT project, the end-goal is now very much in sight. The company took the opportunity to strengthen its balance sheet earlier in the year and has also taken on some new loan facilities.

    Moreover, AVO is looking at novel ways to help purchasers to fund the installation of a LIGHT system, which involves a profit share arrangement based on patient treatments. This shows that AVO is continually looking at opportunities to fund this fascinating project.

    Q5: Is there anything that we can look forward to?

    A5: A number of investors have been following this project since its inception and are realising that many of the risks have now been removed and the first LIGHT system really is not far away, as evidenced by the recent commercial deals. In order to keep investors informed, the company is holding an investor day on Monday 19th October where management and scientific advisors will be available to answer investors questions.

    As for investment, today’s market capitalisation broadly equates to the gross investment by Advanced Oncotherapy to get LIGHT where it is today. There is a big disconnect between fundamental and market valuation which we expect to change as confidence increases that LIGHT will become a reality in the near future. Moreover, Siemens Healthineers has agreed a very handsome price to acquire Varian to gain access to its radiation oncology business.

  • Advanced Oncotherapy the end goal is very much in sight (Analyst Interview)

    Advanced Oncotherapy the end goal is very much in sight (Analyst Interview)

    Advanced Oncotherapy plc (LON:AVO) is the topic of conversation when Dr Martin Hall, Analyst at Hardman & Co joins DirectorsTalk. Martin explains what’s been happening with the company lately, the potential advantages of LIGHT, how close we are to the first system, how AVO is funding all the work and what investors and potential investors can look forward to over the coming months.

    Advanced Oncotherapy is a specialist developer and provider of a breakthrough proton therapy system, the LIGHT system, which is the result of 25 years of work at CERN and ADAM.

    Its focus is on developing and supplying technologies to maximise the destructive effect of radiation on tumours whilst minimising damage to the patient’s healthy tissues.

  • Advanced Oncotherapy funded through to clinical events

    Advanced Oncotherapy funded through to clinical events

    Advanced Oncotherapy (LON:AVO) goal is to deliver an affordable and novel proton therapy (PT) system, called LIGHT, based on state-of-the-art technology developed originally at the world-renowned CERN. Over the past two years, the project has been significantly de-risked through important technical milestones. AVO is working on the verification and validation phase, prior to LIGHT being used on the first patients to support CE certification. A recent equity issue, new loan facilities and some commercial announcements earlier in 2020 highlight the increasing confidence that is building in AVO’s ability to achieve its goal to deliver LIGHT in the near future.

    • Strategy: AVO is developing a compact and modular PT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off), and relies on a world-class supplier base.
    • 2019 results: EBIT was in line with expectations, higher operating costs being offset by lower share-based payments. Introduction of IFRS 16 for lease liabilities does affect the net cash/(debt) calculation, but recent capital increases via an equity issue and new loan facilities have strengthened AVO’s finances.
    • Commercial update: AVO has seen significant commercial traction, with three collaborations announced in early 2020. Its flexible, customer-focused, business model can generate four potential revenue streams: sale of LIGHT systems, maintenance contracts, software licence fees and project management fees.
    • Risks: The more complex technical challenges have been overcome, and progress towards assembling a fully functional accelerator is under way. The annual report highlights the upcoming challenges and how they are being mitigated, with new funding giving financial flexibility to reach the finishing line, despite COVID-19.
    • Investment summary: The EV of £123m equates only to the amount invested into LIGHT to date, which reflects neither the enormous technical challenges that have been overcome, nor the market potential – our DCF valuation is 229p. The market will wake up to this opportunity, as assembly of the first LIGHT system reaches its conclusion and Advanced Oncotherapy applies for CE certification. Commercial deals indicate that buyers are comfortable about the timing of LIGHT delivery.

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  • Advanced Oncotherapy Analyst Q&A discussing the LIGHT collaboration (LON:AVO)

    Advanced Oncotherapy Analyst Q&A discussing the LIGHT collaboration (LON:AVO)

    Advanced Oncotherapy PLC (LON:AVO) is the topic of conversation when Hardman and Co’s Analyst Dr Martin Hall caught up with DirectorsTalk for an exclusive interview.

    Q1: You recently released a report on Advanced Oncotherapy highlighting some interesting developments for the company. Can you tell us what has been going on?

    A1: Until now, the focus of the company’s activities has been on the technical aspects and potential advantages of its new proton therapy system, called LIGHT. All the recent announcements have been about commercial arrangements, which indicates that potential purchasers are comfortable that LIGHT will be completed and validated in the foreseeable future.

    The confidence in a successful outcome with LIGHT and the momentum behind the commercial deals were highlighted in our report.

    Q2: Can you flesh out a little more detail about these commercial deals?

    A2: First, there is a new arrangement with respect to the company’s prestigious Harley Street site. Investors that have been following AVO for some time will recall that the company originally did a deal with Circle Health for the day-to-day management of that site. However, there has been a natural evolution at both companies such that a new deal was needed. They have now signed a 10-year agreement with the also prestigious group, The London Clinic, for the daily operational activities at Harley Street, and will be increasing it to a two-room facility.

    Secondly, the company announced that a LIGHT system will be installed at The Mediterranean Hospital, Cyprus. This is due to be completed by the end of 2023 and the LIGHT system will cost €50m, about £42m at today’s exchange rate.

    Thirdly, and this was announced subsequent to our report, the company announced a collaboration with University Hospitals Birmingham NHS Foundation Trust for the construction and installation of a LIGHT system in Birmingham. This deal was announced subsequent to our research report.

    Q3: Is there anything of note in these deals?

    A3: Financial terms were not disclosed. However, in each case they will be working with its partners such that it will have a profit sharing arrangement with the operators So the significance of these deals is that are structured to increase the log-term cashflows for the company.

    Q4: Can you just bring us up to date with respect to the LIGHT system?

    A4: Yes, at its AGM in July, the company set out a schedule of module deliveries at its UK assembly and testing facility in Daresbury, Cheshire. Progress with this schedule was updated along with its interim results at the end of September, and we provided a further update in the research report.

    All of the modular components, together with the patient positioning system, have been manufactured and either delivered or placed in storage at its UK assembly and testing facility in Daresbury, Cheshire. Currently the modules are being integrated and tested as part of the overall validation process in readiness for the application for CE marking later this year.

    Q5: What was overall conclusion and investment view for Advanced Oncotherapy?

    A5: After several years focusing on the technological and manufacturing challenges of LIGHT, the focus has rapidly changed to commercial execution. These three partnerships represent a step-change for the company and provide an insight into how the company is building its business model.

    As for investment, today’s market capitalisation barely equates to the gross investment by AVO to get LIGHT where it is today. There is a big disconnect between fundamental and market valuation which we expect to change as the market realises that more potential purchasers have the confidence that LIGHT will become a reality in the near future.

  • Advanced Oncotherapy Rapidly changing to commercial execution (Interview)

    Advanced Oncotherapy Rapidly changing to commercial execution (Interview)

    Advanced Oncotherapy plc (LON:AVO) is the topic of discussion when Dr Martin Hall Analyst at Hardman & Co joins DirectorsTalk. Martin talks us through the interesting developments being made at the company, commercial deals, brings us up to date with the LIGHT system and tells us his overall conclusion from his report and the company as an investment case.

    Advanced Oncotherapy is a UK-based company focused on delivering a cost-effective proton-based radiotherapy solution called LIGHT. Based on ground-breaking technology developed and tested at world renowned CERN in Switzerland, the LIGHT system delivers an integrated proton radiotherapy system to treat cancer.

  • Advanced Oncotherapy Confidence in LIGHT gaining momentum

    Advanced Oncotherapy Confidence in LIGHT gaining momentum

    The Advanced Oncotherapy PLC (LON:AVO) goal is to deliver an affordable and novel proton beam therapy (PBT) system, based on state-of-the-art technology developed originally at the world-renowned CERN. In the past 18 months, the project has been de-risked through important technical milestones. AVO is working on the verification and validation phase, prior to CE marking and LIGHT being used on the first patients. The company has made two important commercial announcements regarding the installation of LIGHT systems, which highlights the increasing confidence that is building in AVO’s ability to deliver LIGHT in the near future.

    • Strategy: AVO is developing a compact and modular PBT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off) and relies on a world-class supplier base.
    • Harley Street: Last week, AVO announced a new partnership with The London Clinic (TLC), which will run the day-to-day operational activities for the LIGHT machine at its Harley Street site. Although financial terms were not disclosed, it will have a profit share arrangement that highlights AVO’s innovative business and financing strategy.
    • Mediterranean Hospital of Cyprus: Today, AVO has also announced a purchase order, valued at €50m/£41.7m, for the installation of a LIGHT accelerator system, which will support three treatment rooms. AVO will also receive a share of the profit generated from this PBT service.
    • Risks: Since 2018, the more complex technical challenges have been overcome, and progress towards a fully functional accelerator is under way in readiness for CE marking. Focus is now moving towards commercial execution and management’s ability to have its innovative financing strategy adopted.
    • Investment summary: Advanced Oncotherapy’s market capitalisation of £88m equates only to the amount invested into LIGHT to date, which does not reflect either the enormous technical challenges that have been overcome, or the market potential. DCF analysis of LIGHT’s prospects gives an NPV of at least 229p a share (fully-diluted). The disconnect between fundamental and market valuations offers an interesting investment opportunity at a time when commercial execution is showing through.

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  • Advanced Oncotherapy Proving the accuracy and superiority of minibeams

    Advanced Oncotherapy Proving the accuracy and superiority of minibeams

    The goal of Advanced Oncotherapy (LON:AVO) is to deliver an affordable and more effective proton beam therapy (PBT) system, based on state-of-the-art technology developed originally at the world-renowned CERN. In the past 18 months, the project has been de-risked through important technical milestones. AVO is now working on the verification and validation phase, prior to CE marking and LIGHT being used on the first patients. Meanwhile, AVO has entered into a research collaboration with the Cleveland Clinic aimed at proving the accuracy of targeting cancerous tissue, and sparing normal tissue, with proton minibeams in comparison with other methodologies.

    • Strategy: AVO is developing a compact and modular PBT system, which is affordable for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from technology know-how developed by ADAM (CERN spin-off) and relies on a world-class supplier base.
    • Collaboration: The renowned Cleveland Clinic will undertake a two-year study to evaluate the target conformality of proton minibeams in comparison with stereotactic X-ray radiotherapy currently used for several types of cancer, particularly those located in the brain.
    • Goals: Industry and oncologists are focused on overcoming the key challenge of ensuring that radiotherapy is targeted only at cancerous tissue, and avoiding healthy tissue. LIGHT has been designed for accuracy and improved patient outcomes. It is also being positioned to highlight its commercial advantages.
    • Risks: Since 2018, the more complex technical challenges have been overcome, and progress towards a fully-functional accelerator is under way in readiness for CE marking. Execution risk remains, but management’s ability to raise funding and meet its milestones for the past 30 months has lowered this risk.
    • Investment summary: AVO’s market capitalisation of £93m equates only to the amount invested into LIGHT to date, which does not reflect either the enormous technical challenges that have been overcome or the market potential. A DCF analysis of the LIGHT prospects generates an NPV of at least 224p per share (fully-diluted). The disconnect between fundamental and market valuations offers an interesting investment opportunity, in our opinion.

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  • Advanced Oncotherapy Analyst Q&A with Dr Martin Hall (LON:AVO)

    Advanced Oncotherapy Analyst Q&A with Dr Martin Hall (LON:AVO)

    Advanced Oncotherapy (LON:AVO) is the topic of conversation when Hardman and Co’s Head of Life Sciences Dr Martin Hall caught up with DirectorsTalk for an exclusive interview.

    Q1: You recently released a report on Advanced Oncotherapy highlighting some interesting developments for the company. Can you tell us what has been going on?

    A1: First, at its AGM in July, the company set out a schedule of module deliveries at its UK assembly and testing facility in Daresbury, Cheshire. With its interim results at the end of September the company updated the market on progress.

    Secondly, the Centers for Medicare and Medicaid Services in the US is looking to introduce a new reimbursement model for radiotherapy services, which would be beneficial for proton beam therapy, and AVO in particular.

    Thirdly, oncologists around the world are getting excited about a new method of delivering radiotherapy, called FLASH, which is more damaging to cancerous tissue and far less damaging to normal tissue. Again, the company’s offering is well suited to this new approach.

    Q2: So, taking each of these points in turn, what is happening at Daresbury?

    A2: The LIGHT machine has four major components and a modular construction, which offers many advantages. AVO is assembling a complete machine that will be able to generate a full power proton beam, which will be used to obtain CE marking.

    As far as these modules are concerned, most have now been delivered to Daresbury and the complete set will be there by the end of the year. These will be assembled together and, over coming months, the machine will be validated and verified to very high standards as required by the regulators. Each step of this process is further de-risking the whole project.  

    Q3: Moving on to the second point, what is happening to reimbursement in the US?

    A3: At present, the process of reimbursement, especially for radiotherapy is a rather unwieldy fee-for-service approach, whereby the clinic, system operators, and physicians all submit separate claims for reimbursement. It is in all their interests for the patient to go as many times as possible for treatments, often up to 35 visits, and has become very expensive. What is more, is does not give much consideration to the patient.

    There is a proposal, expected to be ratified and introduced early in 2020, to reverse this and use a reimbursement model driven by patient outcomes. For example, there is a trend to divide the total dose of radiation delivered to patients into several smaller doses, called hypo-fractionation, which results in fewer patient visits. It also maximizes the effect of radiation on cancer and minimises the negative side effects. This new model will encourage greater use of hypo-fractionation which is extremely positive for proton therapy equipment providers, such as AVO.

    Q4: And what exactly is FLASH radiotherapy?

    A4: In very simple terms, this technique allows the use of ultra-high doses of radiation, at least an order of magnitude higher than currently used, divided into multiple small fractions delivered over a very short period of time, milliseconds, in a single visit. This has been shown to have a more damaging effect on cancerous tissue, whilst limiting the impact on healthy tissue. Until now, this has all been done in animal models, but last month the first, excellent, patient outcome was published for a superficial tumour.

    Unsurprisingly, all the equipment manufacturers are looking at how to incorporate FLASH radiotherapy into their systems. However, in this respect, the company is uniquely, and I use that word very rarely, positioned. This is because FLASH needs very precise pencil thin proton beams of very high energy, which the LIGHT system generates and controls electronically.

    In contrast, most of their competitors use cyclotrons to generate proton beams with higher energy than required for treatment and then use degraders to bring the energy level down to the required level, with much of the radiation wasted, and requiring extensive protective shielding. FLASH requires significantly more protons than conventional therapy, exacerbating this situation.

    So FLASH is essentially a super-efficient hypo-fractionation method.

    Q5: Does this impact Advanced Oncotherapy’s valuation?

    A5: These developments do not alter our 229p valuation for the company, which is derived from a DCF model but they all position them well for the future. The validation and verification process reduces the overall risk of the project. When LIGHT does reach the market, it will be extremely well positioned with respect to hypo-fractionation of dose, coupled with the use of FLASH. This, in turn, fits well with the new reimbursement model about to be introduced in the US which is focused more on patient outcomes.

  • Why is Advanced Oncotherapy well positioned for the future?

    Why is Advanced Oncotherapy well positioned for the future?

    Advanced Oncotherapy plc (LON: AVO) is the topic of conversation when Dr Martin Hall, Head of Life Sciences at Hardman & Co joins DirectorsTalk. Martin talks us through some interesting developments at the company, explains what has been happening at Daresbury, Cheshire, Reimbursement in the US, what exactly FLASH radiotherapy is and what impact this all has on the company’s valuation.

    Advanced Oncotherapy’s goal is to deliver an affordable and novel proton beam therapy (PBT) system, based on state-of-the-art technology developed originally at the world-renowned CERN. In the past 18 months, the project has been de-risked through important technical milestones. AVO is working on the verification and validation phase, prior to CE marking and LIGHT being used on the first patients. Proposed changes to the US reimbursement framework are beneficial to PBT as a whole, and the trend towards hypo-fractionation of ultra-high doses in a single patient visit (FLASH), for which LIGHT is uniquely positioned to deliver.

  • Advanced Oncotherapy Important regulatory milestone: ISO approval

    Advanced Oncotherapy Important regulatory milestone: ISO approval

    Hardman & Co Report Report DownloadsAdvanced Oncotherapy (LON:AVO)  goal is to deliver an affordable and novel proton therapy (PT) system, based on state-of-the-art technology developed originally at the CERN. Achievement of major technical milestones has boosted confidence, and the group remains on track with its strategy. AVO has integrated successfully the four types of structure that constitute the LIGHT accelerator and has recorded the proton beam at an energy of 52MeV, sufficient to treat superficial tumours. AVO has just achieved an important regulatory milestone by receiving ISO 13485 accreditation, demonstrating the company’s commitment to safety and high quality, and further endorsing the team’s ability to meet its objectives.

    Strategy: AVO is developing a compact and modular PT system at an affordable price for the payor, financially attractive to the operator, and generating superior patient outcomes. AVO benefits from the technology know-how developed by CERN and ADAM, Geneva, and relies on a base of world-class suppliers.

    ISO approval: ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

    Development update: Infrastructure to support the installation and assembly of the full LIGHT system has already started at STFC’s Daresbury Laboratory. Once the complete system has been installed and validated, it will be used to support AVO’s submission for CE marking, prior to first patients in 2020.

    Risks: With the £10m funding announced in December, AVO is maintening its ability to meet its objectives and keep the pace of its manufacturing plan. Execution risk remains, but the more complex technical challenges have been overcome, and integration of the remaining units is an easy step towards getting the LIGHT accelerator.

    Investment summary: Demand for PT is increasing worldwide, and the need for a small, flexible, affordable and close-to-patient system is desirable. AVO has attracted strong manufacturing and investment partners, and discussions with potential customers are advancing. Progress at the flagship Harley Street site has been substantial, and installation of the first LIGHT system is planned to start in mid-2019. The latest technical update has brought further assurance and boosted confidence.

  • Advanced Oncotherapy Four components integrated

    Advanced Oncotherapy Four components integrated

    Hardman & Co Report Report DownloadsAdvanced Oncotherapy (LON:AVO)  goal is to deliver an affordable and novel proton therapy system (PT), based on
    state-of-the-art technology developed originally at the world-renowned CERN.
    Achievement of major technical milestones has boosted confidence greatly, and the
    group remains on track with its strategy. AVO has successfully integrated the four types
    of structures that constitute the LIGHT accelerator and has overcome technical
    challenges. The proton beam has been recorded at an energy of 52MeV, sufficient to
    treat superficial tumours. With the distribution agreement in place for SE Asia,
    partnerships with both RaySearch and the STFC, and strengthening of its financing
    structure, AVO is now on a much firmer footing.

    Strategy: AVO is developing a compact and modular PT system at an affordable
    price for the payor, financially attractive to the operator, and generating superior
    patient outcomes. AVO benefits from the technology know-how developed by
    ADAM, Geneva, and relies on a base of world-class suppliers.

    ► Major milestone achieved: The biggest technical challenge for the proton
    accelerator has now been overcome. Integration of all the four components at
    CERN’s testing facility in Geneva is, in our opinion, a major milestone that
    significantly de-risks the whole project. AVO now has an accelerator that has
    been powered-up, demonstrated its ability to perform as predicted, and
    accelerated a proton beam to an energy of 52MeV.

    Interims: Investment in LIGHT during 2018 has been broadly in line with our
    forecasts. Moreover, to date in fiscal 2018, AVO has raised ca.£40m, which has
    left the balance sheet debt-free and with net cash of £3.3m, boosted
    subsequently by a Placing (£6.4m gross) and a tax credit of £2.9m, providing
    flexibility in future funding discussions.

    Risks: With funding secured so far in 2018, AVO’s visibility and its ability to
    maintain the fast pace of its development plan have improved. Execution risk
    remains, but the more complex technical challenges have now been overcome,
    and integration of the remaining CCL units is a technically easy step towards
    getting a fully functional accelerator.

    Investment summary: Demand for PT is increasing worldwide, and the need for a
    small, flexible, affordable and close-to-patient system is desirable. Advanced Oncotherapy has
    attracted strong partners, and discussions with potential customers are
    advancing. Progress at the flagship Harley Street site has been substantial and
    installation of the first LIGHT system is planned to start in mid-2019. The latest
    technical update has brought further assurance and boosted confidence.

  • Advanced Oncotherapy LIGHT system remains on-track with reduced overall technology risk profile

    Advanced Oncotherapy LIGHT system remains on-track with reduced overall technology risk profile

    Advanced Oncotherapy Plc (LON:AVO), the developer of next generation proton therapy systems for cancer treatment, announced today its audited results for the year ended 31 December 2017, another year of significant technological development and installation of the Company’s first LIGHT system.

    Key highlights:

    · Successful integration of three of the four key LIGHT system structures significantly reducing technical risk

    · Technological development on-track to be capable of treating superficial tumours by the end of Q3 this year

    · Science and Technology Facilities Council agreement to establish a UK testing and assembly site

    · Harley Street site building work on schedule, first patient treatment expected by the second half of 2020

    · Commercial distribution agreement with Yantai CIPU for China and other parts of Asia

    · Stronger financial position since 31st December 2017 having secured £33.3m of financing post period end

    · Ongoing commercial discussions with sites in the USA, Europe, Asia and Middle East

    Nicolas Serandour, CEO of Advanced Oncotherapy, said: “The technological development of our LIGHT system remains on-track and we continue to proceed with a significantly reduced overall technology risk profile. Similarly work at Harley Street remains on schedule and with additional funding through our licence agreement with Yantai CIPU and the equity fundraise in which they and other investors participated we enter into the second half of 2018 from a stronger position.

    “In 2018 we expect to fire a proton beam through the first CCL module and ultimately produce a beam capable of treating superficial tumours by the end of Q3 2018. The Board remain confident that we can deliver to these timescales and that we will have the financial resources to do so. On behalf of the Board, we would like to thank all of our shareholders for their continued support and belief, and we look forward to further success ahead.”

    Posting of Annual Report & Notice of AGM

    The annual report for the year ended 31 December 2017 will shortly be available from the Company’s website at www.advancedoncotherapy.com and will be posted to shareholders shortly together with a notice of Annual General Meeting to be held at 2.30pm on Wednesday, 25 July 2017 at The Royal Society of Medicine, 1 Wimpole Street, London W1G 0AE.

  • Advanced Oncotherapy Strengthens balance sheet position

    Advanced Oncotherapy Strengthens balance sheet position

    Advanced Oncotherapy Plc (LON:AVO), the developer of next-generation proton therapy systems for cancer treatment, announced today that the Company has received £10 million from Yantai Cipu, through its affiliated entity Liquid Harmony, in relation to the balance of payments due under the Distribution Agreement announced on 7 December 2017. This completes the £30 million investment from Yantai Cipu.

    In addition, the Company announces that further to previous announcements regarding the Bracknor funding facility, all outstanding Convertible Loan Notes (“CLN”) owned by Bracknor are being converted into new ordinary shares of 25p issued (“Ordinary Shares”) at a price of 46p. As part of this transaction, 5,127,560 Ordinary Shares are being issued as a result of the conversion and the satisfaction of the payment of conversion fee and commitment fees (the “Conversion”). The new Ordinary Shares will be immediately transferred to a third party investor called M3T PTE Ltd. M3T PTE Ltd is a Special Purpose Vehicle created by a Singaporean Family Office to hold these Ordinary Shares. As a result, Bracknor no longer holds CLN relating to the Company.

    Application will be made for admission to trading on AIM (“Admission”) of the 5,127,560 new Ordinary Shares deriving from the Conversion and it is expected that Admission will occur on or around 5 June 2018.

    Total voting rights

    Following Admission, the Company’s enlarged issued share capital will comprise 155,629,233 Ordinary Shares, with voting rights. The Company does not hold any Ordinary Shares in treasury. Therefore, the total number of Ordinary Shares in the Company with voting rights will be 155,629,233. This figure may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA’s Disclosure Guidance and Transparency Rules.

    Commenting, Nicolas Serandour, CEO of Advanced Oncotherapy plc, said: “Today’s announcement is a further important step forward in strengthening our balance sheet position. With the completion of our financing arrangement with Yantai Cipu and the placing of the remaining shares due to Bracknor in the hand of a long-term shareholder, we are progressing steadily with our plans of setting our business onto a sustainable path for profitable growth. I want to thank Bracknor for their support since last summer and welcome M3T PTE Ltd as a new shareholder of the Company.”