Advanced Oncotherapy - Interim Results
30/09/2022 07:00
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RNS Number : 2550B Advanced Oncotherapy PLC 30 September 2022
30 September 2022
ADVANCED ONCOTHERAPY PLC
("Advanced Oncotherapy" or the "Company")
Interim Results
Company's first commercial LIGHT accelerator fully operational; achieving a
clinically significant 230 MeV beam, post period
Achievement of a key validating and de-risking corporate milestone
Advanced Oncotherapy (AIM:AVO), the developer of LIGHT, the next-generation
proton therapy system for cancer treatment, today announces its unaudited
results for the six months ended 30 June 2022.
Key highlights (including post-period):
· Continued to progress the Company's first commercial LIGHT
accelerator to be fully operational. Importantly, post-period, as announced on
27 September 2022, a 230 megaelectron volts ("MeV") beam was achieved, a
significant milestone and de-risking event for the Company:
o 230 MeV is the energy required to treat deep-seated tumours at a depth of
32cm;
o Completed the construction of the patient treatment room and installation
of the LIGHT Patient Positioning System ("PPS"), including a state-of-the-art
robotic chair, with CT scanner and X-Ray panels;
o Collected further data on the LIGHT System, including its stability,
intensity and spot size and confirming the advantages of LIGHT; data included
in technical files for certification purposes;
§ A Q-submission process has been agreed with the US Food and Drug
Administration ("FDA") for a potential 510(k) regulatory approval for the
LIGHT system, allowing the Company to submit bundled modules of the 510(k)
submission for feedback, rather than a single submission at the end of
development.
o The Company and University Hospitals Birmingham NHS Foundation Trust
("UHB") will collaborate to start the commissioning process for the treatment
room following a pathway used by all proton therapy machines as part of the
certification process.
· Research published in the International Journal of Medical
Physics and Practice showcased the potential superiority of the LIGHT system
over other existing proton therapy systems in the delivery of FLASH
radiotherapy, further differentiating the Company's LIGHT machine from
cyclotron-based proton therapy systems.
· During the period and post period, the Company raised £13.4
million through share placings to support ongoing business activities.
Nicolas Serandour, CEO of Advanced Oncotherapy, said:
"Over the period, the Company made significant strides towards the delivery of
its first fully operational LIGHT system. Importantly, post-period, in
September 2022, we announced that our LIGHT system accelerator had
successfully generated a proton beam at 230MeV, the energy required to treat
deep-seated tumours at a depth of 32cm. This is the most significant milestone
in the Company's history, validating and de-risking our first commercial LIGHT
machine. As a result of our efforts, we can now move towards the next stage of
this project which will use a pathway followed by all proton therapy systems
for the certification process for the treatment of patients. We anticipate
that the first patient will be treated at the facility in Daresbury in the
second half of 2023. Additionally, we expect the recent validation of the
Company's technology will accelerate the signing of further commercial
contracts with new customers and the advancement of our existing partnership
arrangements.
"We would like to thank both our employees and partners, for their continued
hard-work and dedication, and our shareholders for their ongoing support and
patience. The generation of a 230 MeV proton beam with our unique technology
has been a long process. However, with this key milestone achieved we believe
the Company is well positioned to achieve its vision to defeat cancer through
democratising proton therapy"
Advanced Oncotherapy plc www.avoplc.com (http://www.avoplc.com/)
Dr. Michael Sinclair, Executive Chairman Tel: +44 (0) 20 3617 8728
Nicolas Serandour, CEO
Allenby Capital Limited (Nomad and Joint Broker)
Nick Athanas / Piers Shimwell (Corporate Finance) Tel: +44 (0) 20 3328 5656
Amrit Nahal / Matt Butlin (Sales and Corporate Broking)
SI Capital Ltd (Joint Broker)
Nick Emerson Tel: +44 (0) 1483 413 500
Jon Levinson Tel: +44 (0) 20 3871 4066
FTI Consulting (Financial PR & IR) advancedoncotherapy@fticonsulting.com
(mailto:advancedoncotherapy@fticonsulting.com)
Simon Conway / Rob Winder Tel: +44 (0) 20 3727 1000
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.
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to provide an update to shareholders with our report for the six
months ended 30 June 2022 and I am delighted to highlight the progress the
Company has made in both the period under review and post-period. In
particular, as announced by the Company on 27 September 2022, the Company is
delighted to have completed its first operational LIGHT system accelerator
with a 230MeV beam, the maximum energy required for treating all tumours
regardless of their depth in the body - the most significant milestone in the
Company's history. We believe that over the longer term, LIGHT generated
proton beam therapy could become the preferred modality for external beam
radiotherapy and in particular for difficult-to-treat tumours, eclipsing the
current use of conventional X-ray photon beam radiotherapy, due to its
versatility, precision and cost.
Technology development update
The Company's LIGHT accelerator became fully operational in the evening of 26
September 2022, at its assembly site in Daresbury, Cheshire, UK, generating
proton beams at 230 megaelectron volts ("MeV"), the energy required to treat
deep-seated tumours at a depth of 32cm. This milestone was reached post-period
and reflects the strong progress made by the Company in the first half of the
year on the installation, assembly and commissioning of all the high-precision
accelerating structures, which included (i) the proton source; (ii) the
radio-frequency quadrupole; (iii) the four side-coupled drift tube linacs and;
(iv) the fifteen coupled cavity linacs. The Company also successfully
optimised its machine during the period, showing that it can 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.
Achieving the 230 MeV beam was a breakthrough for Advanced Oncotherapy and the
milestone validates and de-risks the Company's first commercial LIGHT machine.
It also represents the significant 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, which the Board believe is the first commercial
type of its kind.
Alongside the technical and scientific work undertaken in the first half and
post-period, the Company has made good progress in preparing data that will be
submitted to the US Food and Drug Administration ("FDA") on the stability,
intensity and spot size of the proton beam produced by its LIGHT system. These
new data sets demonstrate that the measurements of the quality of the beam
match those from computer simulations and match our internal expectations. We
continue to work with the University Hospitals Birmingham NHS Foundation Trust
("UHB") and Clarivate, a global analytics company, to define the clinical
protocol for treating the first patients. The first patient is anticipated to
be treated in the second half of next year and, as we move closer towards this
significant milestone, we expect to be able to provide a further update on
developments over the next period. The FDA approval process will continue to
be run in parallel with the milestones listed in the outlook section
As well as operational progress, scientific research in proton therapy remains
just as important to our strategy and, in May 2022, we announced the
publication of two papers showcasing the potential superiority of the LIGHT
system over other existing proton therapy systems in the delivery of FLASH. In
the first paper, entitled "Ultra-high dose rate radiation production and
delivery systems intended for FLASH"(1), Jonathan Farr, our Chief Clinical
Officer, and his co-authors, showed that the Company's LIGHT system is ideally
positioned to deliver FLASH, as it is a 'pulsed system' sending out up to 500
million protons in each burst, at 200 times per second. The number of
particles per pulse has been noted as a critical FLASH parameter for other
(electron) systems, and now is becoming available from LIGHT for proton FLASH
treatments. In the second paper, entitled "Treatment planning for FLASH
radiotherapy: General aspects and applications to proton beams"(2), Anna
Kolano, a Medical Physicist at Advanced Oncotherapy, and her co-authors,
highlighted how FLASH could be applied to the LIGHT system for patients
requiring the treatment. FLASH proton therapy is currently administered
clinically with "Shoot-Through FLASH Beams", analogous to X-rays, because
legacy proton systems (cyclotrons) require thick physical beam absorbers to
achieve the lower energies required for patient treatment. By contrast, the
LIGHT system, which can electronically adjust energy levels in the beam, is
designed to deliver FLASH treatments anywhere in the human body. Hence, the
LIGHT FLASH plan for "Conformal Scanned FLASH Beams" is conceptually superior
to the Shoot-Through method.
Commercial update
In line with the Company's strategy and mission, we have continued to build
strategic partnerships to accelerate the commercialisation of the LIGHT system
and democratise proton beam therapy for cancer treatment. Over the period, the
Company continued to make progress with its commercial pipeline and is
exploring additional opportunities for the sale or lease of LIGHT machines to
healthcare providers.
As previously announced in June 2021, the Company 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. This is in addition to
the agreement entered into in February 2020 by the Company with the
Mediterranean Hospital in Cyprus for the installation of a three-treatment
room system in the Mediterranean Hospital.
The Company is also party to two other partnership agreements. A memorandum of
understanding with The London Clinic, whereby the London Clinic will operate
Advanced Oncotherapy's first commercial LIGHT facility on Harley Street in
London, was announced in February 2020. This followed the two-year
collaborative research study announced in December 2019 with Cleveland Clinic.
The Company continues working closely with these two institutions.
The Company believes the LIGHT machine will make proton beam therapy more
affordable and accessible as it has been designed to minimise the costs of
setting up and running a proton therapy centre while maximising patient
throughput. The system is relatively smaller than traditional cyclotron-based
proton therapy machines, is moveable and can be easily installed directly into
clinical facilities. There are only 114 proton beam therapy centres globally,
meaning that only an estimated 87,000 cancer patients can be treated a year.
The cost to cover patient treatment is unsustainable for healthcare systems
and is often out of reach for individual patients. The Company believes that
in the next twenty years the industry will need more than 10,000 additional
proton therapy treatment rooms to meet demand, representing a 50-fold increase
over the current global capacity.
The proton therapy market has seen accelerated growth over the past few years
in both the number of centres in development and the number of patients being
treated. With the introduction of the Company's first operational LIGHT system
to the market, the Board expects the Company's commercial pipeline to
accelerate as a result of this significant milestone.
Equity fundraises
During the period, the Company raised £5.38 million, which was complemented
by a further £8.04 million raised, post period, between 01 July 2022 and 19
August 2022. Proceeds raised through these fundraisings strengthened the
Company's balance sheet ahead of the 230MeV milestone being met and
contributed towards progressing the assembly, documentation, verification and
validation activities associated with our first operational LIGHT system.
Financials
For the period under review, the Company recorded a loss of £15.9 million in
the six months to 30 June 2022 (H1 2021: £12.8 million), with net assets
increasing to £60.5 million over the same period (H1 2021: £36.3 million).
Cash and cash equivalents at 30 June 2022 were £2.5 million (as at 30 June
2021: £725k).
Outlook
With the Company's LIGHT system accelerator now fully operational, the Company
and UHB will collaborate to start the commissioning process for the treatment
room, with the aim of treating the first patient in H2 2023. This will use a
pathway followed by all proton therapy systems as part of the certification
process and the Board believes this milestone has significantly de-risked the
Company's LIGHT system. Upcoming development milestones to be achieved in
collaboration with UHB prior to the first patient being treated 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.
We are confident that there will be increased commercial demand for the LIGHT
system and, in line with our strategy of democratising proton beam therapy, we
will continue to develop our commercial pipeline and progress existing
discussions across the globe for the sale or lease of future LIGHT machines.
The Company has already signed a lessor financing partnership with Kineo
Finance, where it is intended that Kineo will acquire LIGHT systems from the
Company and lease them to customers that are commissioning the LIGHT system.
On behalf of the Board and the rest of the staff, I would like to thank all
our shareholders for their continued support. I look forward to updating the
market on further progress in due course as Advanced Oncotherapy continues on
its journey to democratise proton therapy across the globe.
Dr. Michael Sinclair
Executive Chairman
30 September 2022
1- Farr, J, Grilj, V, Malka, V, Sudharsan, S, Schippers, M. Ultra-High dose
rate radiation production and delivery systems intended for FLASH. Med Phys
2022; 00 1- 37. https://doi.org/10.1002/mp.15659
(https://doi.org/10.1002/mp.15659)
2- Schwarz, M, Traneus, E, Safai, S, Kolano, A, van de Water, S. Treatment
planning for FLASH radiotherapy: General aspects and applications to proton
beams. Med Phys. 2022; 49: 2861- 2874. https://doi.org/10.1002/mp.15579
(https://doi.org/10.1002/mp.15579)
Consolidated statement of profit or loss and other comprehensive income Unaudited Unaudited Audited
Financials in £
6 months to 6 months to year to
30-Jun-22 30-Jun-21 31-Dec-21
Revenue - - -
Cost of sales - - -
Gross profit - - -
Administrative expenses (13,535,664) (11,049,439) (23,736,754)
Operating loss (13,535,664) (11,049,439) (23,736,754)
Finance income - - -
Finance costs (2,417,188) (1,714,047) (5,755,981)
Loss on ordinary activities before taxation (15,952,852) (12,763,486) (29,492,735)
Taxation 77,370 - -
Loss after taxation (15,875,482) (12,763,486) (29,492,735)
Loss for the period
Equity of shareholders of the parent company (15,875,482) (12,763,486) (29,492,735)
Other comprehensive income
Items that will or may be subsequently reclassified to profit or loss:
Exchange differences on translation of foreign operations 2,766,348 (2,294,818) (772,061)
Total comprehensive loss for the period net of tax (13,109,134) (15,058,304) (30,264,796)
Total comprehensive loss attributable to:
Equity of shareholders of the parent company (13,109,134) (15,058,304) (30,264,796)
Non-controlling interests - - -
(13,109,134) (15,058,304) (30,264,796)
Consolidated statement of financial position- Unaudited Unaudited Audited
Financials in £
6 months to 6 months to Year to
30-Jun-22 30-Jun-21 31-Dec-21
Non-current assets
Intangible assets 75,480,905 58,612,197 68,577,370
Property, plant and equipment 7,990,168 7,435,137 7,871,939
Right of use assets 35,970,599 32,790,930 33,183,516
Trade and other receivables 950,898 917,804 927,414
120,392,570 99,756,068 110,560,239
Current Assets
Inventories 29,425,527 24,125,861 25,826,665
Trade and other receivables 847,711 1,550,735 643,319
Cash and cash equivalents 2,507,046 724,696 4,260,490
32,780,284 26,401,292 30,730,474
Total assets 153,172,854 126,157,360 141,290,713
Current liabilities
Trade and other payables (11,532,608) (10,530,997) (5,347,169)
Lease liabilities (2,717,403) (1,366,801) (745,315)
Borrowings (11,704,233) (16,996,691) (10,025,497)
(25,954,244) (28,894,489) (16,117,981)
Non-current liabilities
Licence Fee Received (16,500,000) (16,500,000) (16,500,000)
Lease liabilities (33,040,406) (31,271,501) (32,201,824)
Borrowings (12,280,896) (9,172,782) (10,382,520)
Embedded derivative (4,875,269) (4,000,080) (4,718,960)
(66,696,571) (60,944,363) (63,803,304)
Total liabilities (92,650,815) (89,838,852) (79,921,284)
Net assets 60,522,039 36,318,508 61,369,428
Equity
Share capital 118,338,053 87,458,683 112,903,053
Share premium reserve 67,498,509 63,414,218 71,087,838
Advanced share receipts 5,207,500 - -
Share option reserve 20,773,150 8,819,914 15,959,337
Reverse acquisition reserve 11,038,204 11,038,204 11,038,204
Exchange movements reserve 4,886,473 597,368 2,120,125
Accumulated losses (167,219,850) (135,009,879) (151,739,129)
Equity attributable to shareholders of the Parent Company 60,522,039 36,318,508 61,369,428
Total equity funds 60,522,039 36,318,508 61,369,428
Consolidated statement of changes in equity
Six months to 30 June 2022
Financials in £
Share capital Share premium reserve Share option reserve Advanced share receipts
Balance at 01 January 2021 83,359,894 61,442,782 7,675,332 -
Loss for the year - - - -
other comprehensive income exchange movement - - - -
Total comprehensive Income - - - -
Shares Issued in the period 29,543,159 16,514,884 - -
Expenses deducted from share premium - (1,194,556) - -
Share based payments - (5,675,272) 5,675,272 -
Lapsed options - - - -
Lapsed warrants - - (257,045) -
Share based payments -
- Share option charge - - 2,421,599 -
- Share warrants charge - - 206,859 -
Balance at 31 December 2021 112,903,053 71,087,838 15,722,018 -
Reverse acquisition reserve Exchange movement reserve Accumulated losses Total equity share holders interest
Balance at 01 January 2021 11,038,204 2,892,186 (122,266,120) 44,142,278
Loss for the year - - (29,492,735) (29,492,735)
other comprehensive income exchange movement - (772,061) - (772,061)
Total comprehensive Income - (772,061) (29,492,735) (30,264,796)
Shares Issued in the period - - - 46,058,043
Expenses deducted from share premium - - - (1,194,556)
Lapsed options - - - -
Lapsed warrants - - 257,045 -
Share based payments
- Share option charge - - - 2,421,599
- Share warrants charge - - - 206,859
Balance at 31 December 2021 11,038,204 2,120,125 (151,501,810) 61,369,429
Share capital Share premium reserve Share option reserve Advanced share receipts
Balance at 01 January 2022 112,903,053 71,087,838 15,722,018 -
Loss for the year - - - -
other comprehensive income exchange movement - - - -
Total comprehensive Income - - - -
Shares Issued in the period 5,435,000 - - -
Expenses deducted from share premium - (3,589,329) 3,536,229 -
Receipt of funds - - - 5,207,500
Lapsed options - - - -
Lapsed warrants - - (157,442) -
Share based payments -
- Share option charge - - 731,769
- Share warrants charge - - 940,577
Group provision for minority interest - - - -
Balance at 30 June 2022 118,338,053 67,498,509 20,773,150 5,207,500
Reverse acquisition reserve Exchange movement reserve Accumulated losses Equity share holders interest
Balance at 01 January 2022 11,038,204 2,120,125 (151,501,810) 61,369,428
Loss for the year - - (15,875,482) (15,875,482)
other comprehensive income exchange movement - 2,766,348 - 2,766,348
Total comprehensive Income - 2,766,348 (15,875,482) (13,109,135)
Shares Issued in the period - - - 5,435,000
Expenses deducted from share premium - - - (53,100)
Receipt of funds - - 5,207,500
Lapsed options - - -
Lapsed warrants - - 157,442 -
Share based payments -
- Share option charge - - - 731,769
- Share warrants charge - - - 940,577
Group provision for minority interest - - -
Balance at 30 June 2022 11,038,204 4,886,473 (167,219,850) 60,522,039
Consolidated statement of cash flows- Unaudited Unaudited Audited
Financials in £
6 months to 6 months to year to
30-Jun-22 30-Jun-21 31-Dec-21
Group Group Group
Cash flow from operating activities
Loss after taxation (15,875,482) (12,763,486) (29,492,735)
Adjustments to cash flows from non-cash items
Depreciation of property, plant and equipment 602,632 472,561 1,044,530
Amortisation of right of use assets 672,073 641,707 1,294,725
Finance income - - -
Finance costs 2,109,978 1,293,385 3,603,480
Taxation - - -
Share based payments 1,672,346 1,164,308 2,628,458
Foreign exchange 921,246 (2,472,666) 3,272,736
Cash flows from operations before changes in working capital (9,897,208) (11,664,191) (17,648,807)
Changes in inventories (3,598,862) (1,987,538) (9,188,342)
Change in trade and other receivables (305,246) 351,519 1,249,325
Change in trade and other payables 6,391,081 3,047,397 (3,982,181)
Cash (used) / generated from operations (7,410,235) (10,252,813) (29,570,005)
Corporation Tax Receipt 77,370 - -
Cash flows from operating activities (7,332,865) (10,252,813) (29,570,005)
Cash flows from investing activities:
Other income - - -
Purchase of buildings plant and equipment (760,521) (1,196,921) (2,222,647)
Capital expenditure on intangible assets (4,389,748) (1,742,782) (7,072,083)
Cash flows from investment activities (5,150,269) (2,939,703) (9,294,730)
Cash flows from financing activities:
Proceeds from issue of ordinary shares 5,435,000 6,385,012 43,564,416
Costs of share issue (53,100) (314,787) 1,299,072
Advance share receipts 5,207,500 - -
Interest paid (110,722) (45,750) (294,494)
Long term loan receipts - - -
Lease payments (1,286,805) (1,363,460) (3,781,009)
Short term loan receipts 1,500,000 6,957,375 7,850,000
Short term loan repayments - (7,850,000)
Cash flows from financing activities 10,691,874 11,618,390 40,787,985
Increase/(decrease) in cash and cash equivalents (1,791,260) (1,574,127) 1,923,249
Exchange gain on cash and cash equivalents 37,816 (18,628) 19,789
Cash and cash equivalents at the beginning of the period 4,260,490 2,317,451 2,317,451
Cash and cash equivalents at the end of the period 2,507,046 724,696 4,260,490
Notes to Tables
The same accounting policies, presentation and methods of computation are
followed in the interim consolidated financial information as were applied in
the Group's latest annual audited financial statements except for those that
relate to new standards and interpretations effective for the first time for
periods beginning on (or after) 1 January 2022, and will be adopted in the
2022 annual financial statements. There have been no new standards or
interpretations issued which are expected to have a material impact on the
financial statements.
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