Interim Results

RNS Number : 6094O

Angle PLC

31 January 2019

 

For Immediate Release

31 January 2019

ANGLE plc

("ANGLE" or "the Company")

Interim Results for the six months ended 31 October 2018

ENROLMENT OF FDA BREAST CANCER STUDY 92% COMPLETE  

SAMPLE-TO-ANSWER SYSTEM (PARSORTIX-HYCEAD-ZIPLEX) DEVELOPED FOR NEW OVARIAN CANCER STUDY

LEVERAGED PARTNERSHIP STRATEGY DIFFERENTIATES BUSINESS

ANGLE plc (AIM: AGL and OTCQX: ANPCY), a world-leading liquid biopsy company, today announces its unaudited interim financial results for the six months ended 31 October 2018. 

Operational Highlights 

·     The FDA metastatic breast cancer clinical study in the US has now enrolled over 92% (369 of 400) of the required number of subjects with the clinical and analytical studies expected to be completed in Q1 CY2019

·     Development of the recently acquired HyCEAD Ziplex platform demonstrating exceptionally high sensitivity of detection of a single cancer cell harvested by the Parsortix system opens a range of new market opportunities

·     Ovarian cancer test combining Parsortix system and HyCEAD Ziplex technology successfully developed with clinical verification study pending ethics approval with the pre-study expected to commence in Q1 CY2019

·     Leveraged partnership strategy delivers further validation, new uses and commercial progress with key outputs including:

-  presentation of ANGLE and QIAGEN work on the combination of their technologies to harvest and analyse cells respectively in prostate cancer at an international symposium held in France

-  major independent study published in the journal Cell demonstrates the Parsortix system isolates fragile CTC clusters with very high efficiency. Existing drugs cleared by the FDA for non-cancer indications dissociated CTC clusters in mouse models virtually eliminating metastatic spread of cancer.  If repeated in humans, there is potential for routine use of the Parsortix system in a new approach to cancer treatment

-  study published in the International Journal of Cancer identifies a new application for the Parsortix system in analysing cancer cells in lymph nodes to improve sensitivity and reduce costs.  The process was evaluated in melanoma and may be applicable to all cancers where lymph node analysis is required

-  pilot study demonstrated capability of the Parsortix system to harvest fetal cells from pregnant women's blood for further analysis.  ANGLE is pursuing partnership options for opportunities in the billion dollar non-invasive pre-natal diagnostics market

·     Over 60,000 blood samples processed and an installed base of c. 200 Parsortix instruments as of 31 October 2018 has led to a growing body of published evidence from internationally recognised cancer centres with 16 peer reviewed publications to date

Financial Highlights

·     Revenue and grant income of £0.4 million (H1 2018: £0.2 million)

 

·     Loss from continuing operations of £4.2 million (H1 2018: loss £3.4 million) reflecting planned investment

 

·     Successful fundraising from institutional investors raising gross proceeds of £12.7 million. Proceeds net of expenses were £12.0 million

·     Cash balance at 31 October 2018 of £14.9 million (30 April 2018: £7.6 million) 

Garth Selvey, Chairman, commented:

"The first half of the year has been one of continued progress by ANGLE and we look forward to completing our FDA clinical and analytical studies in metastatic breast cancer in the US in Q1 CY2019 with only 31 more subjects to recruit.  Significant progress has also been achieved in the optimisation of our recently acquired HyCEAD Ziplex platform for downstream analysis in preparation for our ovarian cancer clinical verification study. Our ability to build on these opportunities was enhanced by a successful placing of shares that further strengthened our financial position.

"We also announced successful studies indicating our technology may have a key role in the breakthrough cancer treatment of targeting CTC clusters, in the analysis of lymph nodes, and in non-invasive prenatal diagnostics. Partnership collaborations are central to our commercial strategy and it was encouraging to see positive results from our work with QIAGEN delivering joint co-marketing materials.

"ANGLE has strong competitive differentiation and is well positioned to become a major player in the growing liquid biopsy market, providing unique patent protected technologies with the capability to transform cancer patient care by improving patient outcomes and reducing healthcare costs."

Analyst meeting and webcast details

A meeting for analysts will be held at 12:30pm on 31 January 2019 at the offices of FTI Consulting, 200 Aldersgate, Aldersgate Street, London EC1A 4HD.  Please contact FTI Consulting on 020 3727 1000 for details.

To listen to the live webcast of the analyst meeting, please see

http://www.angleplc.com/investor-information/investor-centre/ for details.

For further information ANGLE:

ANGLE plc	[phone]
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker) Corporate Finance - Carl Holmes, Simon Hicks, Max Bullen-Smith ECM - Alice Lane	[phone]
WG Partners (Joint Broker) Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee	[phone]
FTI Consulting Simon Conway, Stephanie Cuthbert, Ciara Martin Matthew Ventimiglia (US)	[phone] [phone]

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

This announcement contains inside information.

These Interim Results may contain forward-looking statements. These statements reflect the Board's current view, are subject to a number of material risks and uncertainties and could change in the future. Factors that could cause or contribute to such changes include, but are not limited to, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development and commercialisation strategies, the uncertainties related to regulatory clearance and the acceptance of the Group's products by customers.

CHAIRMAN'S STATEMENT

Introduction

Our work towards an FDA clearance of the Parsortix system for use in metastatic breast cancer continued to progress with enrolment for the clinical study now nearing completion, with only 31 subjects left to recruit out of the 400.  Both clinical and analytical studies remain on track, offering the prospect of FDA filing and potential clearance in the 2019 calendar year.

We made further progress with the optimisation of our HyCEAD Ziplex downstream analysis platform, which is now performing even better than it did when setting best in class standards during the ovarian cancer test results presented in early 2018. Following continued development of ANGLE's sample-to-answer system (Parsortix-HyCEAD-Ziplex) ovarian assay, a clinical verification study has been designed and is pending ethics approval with the pre-study due to commence enrolment in Q1 CY2019.

A breakthrough study by the University of Basel, announced on 10 January 2019, reported research into CTC clusters, enabled by the Parsortix system's unique technology, and identified drugs approved by the FDA for non-cancer conditions capable of dissociating CTC clusters, which lead to an 80x reduction of metastasis in mouse models.  If similar efficacy is achieved in humans, there is the potential for routine repeat use of the Parsortix system in a clinical diagnostic setting.

'Sample-to-answer' is key to our commercial strategy, and our partnerships with established companies, including Abbott, QIAGEN and Philips, offer an opportunity for our Parsortix system to work with their analytical technologies to improve the product offering provided to their existing global customer bases. Abbott's technology is being tested in our breast cancer FDA study in the US, while progress has been made in our research project in rectal and breast cancer with Philips. Our partnership with QIAGEN advanced in the first half of the year with co-marketing research results and literature being published at an international symposium held in France demonstrating how our CTC harvesting using the Parsortix system could be combined with QIAGEN's downstream AdnaTest analytical technology to create a vertically integrated offering in prostate cancer.

The Company was pleased to announce several appointments which brought valuable knowledge and experience to both the Board and the Scientific Advisory Board. Dr. Jan Groen was appointed a Non-Executive Director. He is currently President and CEO of MDxHealth, a publicly-traded company specialising in the development and commercialisation of diagnostic tests in urological cancers. In addition, we appointed Mr Greg Shaw and Dr. Joseph D Khoury as Scientific Advisors to the Company. Mr Shaw is a Consultant Urological Surgeon at University College Hospital in London and has published widely on prostate cancer diagnostics and treatment. Dr. Khoury is Professor of Pathology and Laboratory Medicine at the University of Texas MD Anderson Cancer Center in Houston, Texas and is a recognised expert in diagnostic hematopathology.

Results

Revenue and grant income of £0.4 million (H1 2018: £0.2 million) came mainly from research use of the Parsortix system. As occurred in the prior year, revenues are expected to increase in the second half. As at 31 October 2018, over 60,000 blood samples have been processed and there is an installed base of c. 200 Parsortix instruments. Leading international research centres continue to increase their usage of the Parsortix system and with the expanding research use, there is a growing body of evidence which is expected to drive adoption of the system with more widespread use in clinical applications and drug trials.

Planned investment to develop and validate the clinical application and commercial use of the Parsortix and HyCEAD Ziplex systems increased, resulting in operating costs of £5.3 million (H1 2018: £4.2 million). The HyCEAD Ziplex system was acquired 1 November 2017 so there are no related costs in H1 2018. Thus the resulting loss for the period correspondingly increased to £4.2 million (H1 2018: £3.4 million).

The cash balance was £14.9 million at 31 October 2018 (30 April 2018: £7.6 million).  The financial position was strengthened during the half year with a successful placing of shares with institutional investors, which raised gross proceeds of £12.7 million. Proceeds net of expenses were £12.0 million.

Strategy

ANGLE has made progress in its four pronged strategy for achieving widespread adoption of its Parsortix and HyCEAD Ziplex systems in the emerging multi-billion dollar liquid biopsy market:

1)  Completion of rigorous large-scale clinical studies run by leading cancer centres, demonstrating the effectiveness of different applications of the system in cancer patient care

2)  Securing regulatory approval of the system with the emphasis on FDA clearance as the de facto global gold standard.  ANGLE is seeking to be the first company ever to gain FDA clearance for a system which harvests circulating tumour cells (CTCs) from blood for subsequent analysis

3)  Establishing a body of published evidence from leading cancer centres showing the effectiveness of the system through peer reviewed publications, scientific data and clinical research evidence, highlighting a wide range of potential applications

4)  Establishing partnerships with large healthcare companies for market deployment and development of multiple other clinical applications incorporating the Parsortix and/or HyCEAD Ziplex systems.

All four elements are necessary to achieve major success.

Progress towards FDA clearance

Enrolment in ANGLE's metastatic breast cancer clinical study continued towards completion. Of the 400 subjects planned for the clinical study (200 healthy volunteers and 200 metastatic breast cancer patients), distributed across four leading US cancer centres, the number enrolled has risen to 369, over 92% complete, as of 30 January 2019 and it is expected that both clinical and analytical studies will be completed in Q1 CY2019, offering the prospect of FDA filing and potential clearance in the 2019 calendar year. The timing of FDA regulatory clearance is dependent on the FDA's review and response to our submission.

The results of these studies are expected to verify the capabilities of the Company's Parsortix system with the potential for ANGLE to become the first ever company to receive FDA de-novo clearance for a product harvesting intact CTCs from patient blood for subsequent analysis.  This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings.

ANGLE is working with corporate partner Abbott, testing their downstream analytical technology as part of the FDA clinical study. Abbott is the market leader in providing FISH tests for HER-2 testing of tissue biopsies in breast cancer.  ANGLE is using the same FISH test on cancer cells obtained from a blood test.  If successful, this could pave the way for repeat HER-2 testing in breast cancer and open up new markets for Abbott's FISH tests requiring pre-processing of blood using Parsortix.

Extensive work has been undertaken by ANGLE and the US cancer centres on the metastatic breast cancer clinical and analytical studies to ensure they meet FDA requirements. The process has involved significant new learning and expertise and evidence gained should further differentiate the Parsortix system from current market alternatives.

HyCEAD Ziplex downstream analysis platform

Following excellent performance in the Company's ovarian cancer study, ANGLE acquired the downstream analysis HyCEAD Ziplex platform in November 2017.  Combining novel chemistry and a proprietary three-dimensional, flow through micro-array, the patent-protected platform has the ability to perform multiplex gene expression of the cells harvested by the Parsortix system, providing information on more than 100 genes simultaneously from a single reaction.  The platform can be used for DNA, RNA and protein analysis on a wide variety of sample types and applications.  ANGLE's use of the platform in its ovarian cancer study for RNA analysis enabled the development of an algorithm to predict the presence of malignancy which showed a much higher level of sensitivity and specificity than current standard of care approaches.

Following the acquisition, ANGLE has successfully completed extensive developments to incorporate a number of improvements to the platform delivering a more robust and reproducible system with even higher levels of analytical sensitivity.  A detailed market review was undertaken to identify key user requirements and optimisation work has been completed to address these with key improvements including:

·     analytical sensitivity sufficient to detect and analyse a single cancer cell in a Parsortix harvest from whole blood

·     process controls incorporated to track assay and instrument performance

·     patient blood stability demonstrated for up to 96 hours enabling the test to be offered by large scale central laboratories with sufficient time for sample transportation.

As well as integrating extremely well with the Parsortix system, the HyCEAD Ziplex platform has the potential to open new markets for ANGLE, as it can be deployed with many other sample types and not just CTCs. HyCEAD Ziplex is well positioned for the routine analysis of clinically actionable, targeted gene panels as a lower cost alternative to sequencing. Now that the HyCEAD Ziplex system has been further optimised and characterised, discussions can be progressed with a variety of potential customers and partners. 

Ovarian cancer test

Following the highly successful results of the ovarian cancer study combining the Parsortix system to harvest CTCs and the HyCEAD Ziplex platform to provide RNA expression analysis of the harvested cells, ANGLE has completed further extensive development and verification of the ovarian assay.

The entire "sample-to-answer" process has been analytically validated and is now ready to be evaluated in the clinical setting.  A clinical verification study has been designed and submitted to the University of Rochester Wilmott Cancer Center for ethics review and approval. The pre-study is expected to commence in Q1 CY2019, with completion of the clinical verification study expected 12 months later.  Once the new performance data is available and, assuming its results are comparable to the first study, ANGLE intends to engage with large clinical laboratories and/or women's health companies with existing sales and distribution channels for clinical deployment

Approximately 5-10% of women in the US will be diagnosed with abnormal pelvic masses in their lifetime. Of these, a significant minority (15-20%) will be malignant.  ANGLE's non-invasive test has the potential to significantly out-perform current clinical care in discriminating malignant from benign pelvic masses. This would allow patients to be triaged to appropriate surgery with the dual benefit of improving outcomes and reducing healthcare costs.  

The improved HyCEAD Ziplex platform demonstrates improved performance compared to the version deployed in our previous ovarian cancer pelvic mass triage study that achieved best in class predictive accuracy of 95.1%. Enhancements to ANGLE's liquid biopsy workflow now offer the ability to detect and analyse a single cancer cell from up to 10mL of whole blood.

The clinical verification study will help support the launch of a clinical assay at a large clinical laboratory and/or via a commercial partnership. 

Additional studies underline potential of Parsortix system

The body of evidence continues to grow and there are now 16 peer-reviewed publications and numerous posters reporting on the use of the Parsortix system.

Harvesting of CTC clusters enabled by Parsortix

Ground-breaking research by a customer, the University of Basel, demonstrated that the Parsortix system could be used to harvest CTC clusters from the blood samples of cancer patients. Investigation of these CTC clusters, enabled by use of the Parsortix system, led to the identification of several drugs cleared by the FDA for other non-cancer indications which could dissociate the clusters into individual cells. 

CTC clusters are known to be highly efficient forerunners of metastasis, which is the primary way in which cancer spreads and is responsible for more than 90% of cancer-related deaths. When tested in a mouse model, the drugs reduced the metastatic spread of the disease by a factor of 80 (untreated mice had 80x more metastasis than treated mice) and the metastatic spread of the cancer was virtually eliminated in the treated mice.

The new approach to dissociate CTC clusters would be additional to existing treatment approaches.  It is also expected to have lower levels of toxicity because conventional chemotherapy seeks to kill cancer cells and is consequently inherently toxic, with the potential for patients to suffer serious side effects from treatment as non-cancer cells may also be adversely affected. 

If the human study now being planned by the University of Basel in breast cancer confirms similar benefit in cancer patients as seen in the animal models, there is the potential for the Parsortix system to be used in a routine clinical diagnostic setting on a repeat basis with every cancer patient to determine whether they have CTC clusters and might therefore benefit from the new approach.  Parsortix is the only commercially available system proven to work with CTC clusters.

Treatment of brain cancer

The University of Basel also reported on the ability to harvest cancer cells from the blood samples of brain cancer patients using the Parsortix system. Up until the publication of this research, the view was that CTCs and CTC clusters could not pass through what is referred to as the blood-brain barrier, a semi-permeable border that separates circulating blood from the brain itself. The study is of particular significance as it may allow a Parsortix-based liquid biopsy to be used where access to the tissue in the brain is not possible or desirable.

Lymph node analysis

Assessment of the spread of cancer to the nearby lymph nodes is a key factor for prognosis and staging in many cancers including melanoma, lung, head & neck, colorectal, prostate and breast cancers.

Customer, Fraunhofer Institute for Toxicology and Experimental Medicine (Regensburg, Germany), has developed a new process for analysing lymph nodes, which they have published in the International Journal of Cancer. The work was undertaken in melanoma but may be applicable to all cancers where lymph node dissection is required.

Fraunhofer have shown that the use of Parsortix in lymph node analysis can improve laboratory efficiency, reduce costs and improve medical decision-making and patient care. This opens the potential to expand use of the Parsortix system beyond the analysis of blood to improve the analysis of other sample types. 

Having developed a method for disaggregating lymph nodes into single cells to facilitate analysis, Fraunhofer tested other CTC systems to try to automate the process of analysis of the cells.  Neither antibody-based and nor membrane-based CTC systems were suitable for the process.  The Fraunhofer work demonstrates another new area of potential use for Parsortix where the product has key competitive differentiation.

Non-invasive prenatal testing

Following an in-house pilot study, ANGLE announced results demonstrating that the Parsortix system could harvest fetal cells from the blood of pregnant women. The detection of fetal abnormalities by analysis of fetal cells as opposed to cell free fetal DNA (tiny fragments of dead cells) could greatly extend the applicability of the process while addressing key limitations in existing approaches.

In recent years there has been a move away from invasive procedures such as amniocentesis to obtain and analyse the cells of an unborn child for possible abnormalities. Up until this point, the non-invasive option has been limited to the analysis of fragments of dead fetal cells co-mixed with maternal blood. The limited nature of this sample restricts the breadth of analysis that can be performed; in spite of this the technique has met with broad commercial success.

With the capability of the Parsortix system to harvest intact fetal cells from pregnant women's blood, it may be possible to undertake more extensive evaluations of fetal health than existing non-invasive prenatal testing (NIPT) techniques currently offer.

The NIPT market is expected to reach $1.0 billion in market size by 2022. ANGLE plans to progress commercialisation of Parsortix in this market through commercial partnerships with one or more large healthcare companies.  Discussions are in progress with a number of such companies.

Progressing partnerships with large healthcare companies

ANGLE has a strategy of developing corporate partnerships with large, global healthcare companies with the resources and footprint to accelerate commercial development within relevant markets. These relationships provide an opportune means of gaining sales and distribution channels as well as access to larger economic resources. The Company currently has three such partnerships in place and each made progress.

Abbott

Abbott is supplying ANGLE with its proprietary PathVysion FISH probe kits to be used in the Company's metastatic breast cancer clinical study. ANGLE's Parsortix system will harvest circulating tumour cells and Abbott's FISH technology will enable the evaluation of the HER-2 amplification status of the harvested CTCs. Abbott is the market leader in FISH testing of tissue biopsies for breast cancer to assess whether a patient may benefit from the drug Herceptin and there is the potential for Abbott to encourage the adoption of the Parsortix system so that its same product can be used for subsequent testing using blood samples to determine the patient's current HER-2 status.

QIAGEN

The partnership with QIAGEN, a world-leading molecular testing company, progressed well during the half year. The upstream harvesting capabilities of ANGLE's Parsortix system is being combined with the downstream analytical technologies of QIAGEN to create a 'sample to answer' solution first in prostate cancer research. A significant step forward was achieved with the co-marketing of the combined product offering at an international cancer conference in France which presented on the potential for application within prostate cancer testing.

Philips

The research project with Philips is under way to harvest and analyse circulating tumour cells in the areas of breast and rectal cancers. This is a four-year European Union research grant funded programme working with Philips to assess the combination of liquid biopsy solutions with their imaging solutions.

Potential additional partnerships

Additional corporate partnerships are being discussed for the Parsortix and HyCEAD Ziplex platforms.

Outlook

The Company has continued to demonstrate the efficacy and significant commercial potential of the Parsortix system through its own clinical studies and the growing number of commercial opportunities that are emerging from our partnership strategy.   

Results from the FDA metastatic breast cancer studies in the US, accompanied by further developments in our ovarian cancer clinical verification study, will provide more evidence to support the view that the Parsortix and HyCEAD Ziplex platforms are superior technologies that are gaining increasing acceptance as strongly differentiated solutions in the growing liquid biopsy market.

Garth Selvey

Chairman

30 January 2019

ANGLE plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 31 OCTOBER 2018

	Note	Six months ended	Six months ended	Year ended
		31 October	31 October	30 April
		2018	2017	2018
		(Unaudited)	(Unaudited)	(Audited)
		£'000	£'000	£'000
Revenue		273	188	628
Cost of sales		(69)	(54)	(169)
Gross profit		204	134	459
Other operating income		97	-	52
Operating costs		(5,340)	(4,245)	(9,444)
		________	________	________
Operating profit/(loss)		(5,039)	(4,111)	(8,933)
Net finance income/(costs)		10	1	8
Profit/(loss) before tax		(5,029)	(4,110)	(8,925)
Tax (charge)/credit	3	781	680	1,387
Profit/(loss) for the period		(4,248)	(3,430)	(7,538)
Other comprehensive income/(loss) Items that may be subsequently reclassified to profit or loss
Exchange differences on translating foreign operations		104	(36)	(99)
Other comprehensive income/(loss)		104	(36)	(99)
Total comprehensive income/(loss) for the period		(4,144)	(3,466)	(7,637)
		========	========	========
Profit/(loss) for the period attributable to:
Owners of the parent		(4,258)	(3,438)	(7,556)
Non-controlling interests		10	8	18
		________	________	________
Profit/(loss) for the period		(4,248)	(3,430)	(7,538)
		========	========	========
Total comprehensive income/(loss) for the period attributable to:
Owners of the parent		(4,068)	(3,467)	(7,702)
Non-controlling interests		(76)	1	65
		________	________	________
Total comprehensive income/(loss) for the period		(4,144)	(3,466)	(7,637)
		========	========	========
Earnings/(loss) per share attributable to owners of the parent
Basic and Diluted (pence per share)	4	(3.29)	(4.58)	(7.91)

  All activity arose from continuing operations

ANGLE plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 OCTOBER 2018

	Note	31 October	31 October	30 April
		2018	2017	2018
		(Unaudited)	(Unaudited)	(Audited)
		£'000	£'000	£'000
Non-current assets
Intangible assets	5	5,797	2,160	5,588
Property, plant and equipment		1,403	849	1,475
		_________	_________	_________
Total non-current assets		7,200	3,009	7,063
		_________	_________	_________
Current assets
Inventories		880	854	599
Trade and other receivables		673	1,478	828
Taxation		1,918	1,440	2,147
Cash and cash equivalents		14,874	4,281	7,645
		_________	_________	_________
Total current assets		18,345	8,053	11,219
		_________	_________	_________
Total assets		25,545	11,062	18,282
		============	============	============
Current liabilities
Trade and other payables		(1,684)	(1,621)	(2,398)
		_________	_________	_________
Total current liabilities		(1,684)	(1,621)	(2,398)
		_________	_________	_________
Total liabilities		(1,684)	(1,621)	(2,398)
		_________	_________	_________
Net assets		23,861	9,441	15,884
		============	============	============
Equity
Share capital	6	14,249	8,605	11,709
Share premium		52,905	36,081	43,449
Share-based payments reserve		1,182	997	1,072
Other reserve		2,553	2,553	2,553
Translation reserve		176	103	(14)
Retained earnings		(46,372)	(38,078)	(42,129)
ESOT shares		(102)	(102)	(102)
		_________	_________	_________
Equity attributable to owners of the parent		24,591	10,159	16,538
Non-controlling interests		(730)	(718)	(654)
		_________	_________	_________
Total equity		23,861	9,441	15,884
		============	============	============

ANGLE plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE SIX MONTHS ENDED 31 OCTOBER 2018

	Six months ended	Six months ended	Year ended
	31 October	31 October	30 April
	2018	2017	2018
	(Unaudited)	(Unaudited)	(Audited)
	£'000	£'000	£'000
Operating activities
Profit/(loss) before tax from continuing operations	(5,029)	(4,110)	(8,925)
Adjustments for:
Depreciation of property, plant and equipment	295	191	446
(Profit)/loss on disposal of property, plant and     equipment	8	-	1
Amortisation and impairment of intangible assets	317	84	344
Exchange differences	(1)	(4)	(33)
Net finance (income)/costs	(10)	(1)	(8)
Share-based payments	125	182	324
Operating cash flows before movements in working capital:	(4,295)	(3,658)	(7,851)
(Increase)/decrease in inventories	(254)	(309)	(83)
(Increase)/decrease in trade and other receivables	160	280	(106)
Increase/(decrease) in trade and other payables	(835)	(457)	727
Operating cash flows	(5,224)	(4,144)	(7,313)
Research and development tax credits received	1,070	501	501
Net cash from/(used in) operating activities	(4,154)	(3,643)	(6,812)
Investing activities
Purchase of property, plant and equipment	(185)	(344)	(1,031)
Purchase of intangible assets	(454)	(353)	(830)
Acquisition of assets and business	-	-	(3,613)
Interest received	10	1	8
Net cash from/(used in) investing activities	(629)	(696)	(5,466)
Financing activities
Net proceeds from issue of share capital	11,996	3,086	14,391
Net cash from/(used in) financing activities	11,996	3,086	14,391
Net increase/(decrease) in cash and cash equivalents	7,213	(1,253)	2,113
Cash and cash equivalents at start of period	7,645	5,536	5,536
Effect of exchange rate fluctuations	16	(2)	(4)
Cash and cash equivalents at end of period	14,874	4,281	7,645
	=======	=======	=======

ANGLE plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 31 OCTOBER 2018

------------------------------------------------- Equity attributable to owners of the parent ---------------------------------------------------------
			Share-based
	Share	Share	payments	Other
	capital	premium	reserve	reserve
	(Unaudited)	(Unaudited)	(Unaudited)	(Unaudited)
	£'000	£'000	£'000	£'000
At 1 May 2017 (Audited)	7,482	33,285	822	2,553
For the period to 31 October 2017
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations
Total comprehensive income/(loss)
Issue of shares (net of costs)	1,123	2,796
Share-based payments			182
Released on forfeiture			(7)
	___ ______	___ _______	___ ______	___ ______
At 31 October 2017 (Unaudited)	8,605	36,081	997	2,553
For the period to 30 April 2018
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations
Total comprehensive income/(loss)
Issue of shares (net of costs)	3,104	7,368
Share-based payments			142
Released on forfeiture			(67)
	___ _______	___ _______	___ _______	___ _______
At 30 April 2018 (Audited)	11,709	43,449	1,072	2,553
For the period to 31 October 2018
Consolidated profit/(loss)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations
Total comprehensive income/(loss)
Issue of shares (net of costs)	2,540	9,456
Share-based payments			125
Released on forfeiture			(15)
	___ ______	___ _______	___ ______	___ ______
At 31 October 2018 (Unaudited)	14,249	52,905	1,182	2,553
	==========	==========	==========	==========

------------------------------------------- Equity attributable to owners of the parent ------------------------
		Retained	ESOT	Total Shareholders'	Non-controlling		Total
	Translation	earnings	shares	equity	interests		Equity
	reserve	(Unaudited)	(Unaudited)	(Unaudited)	(Unaudited)		(Unaudited)
	(Unaudited)	£'000	£'000	£'000	£'000		£'000
	£'000
At 1 May 2017 (Audited)	132	(34,647)	(102)	9,525	(719)		8,806
For the period to 31 October 2017
Consolidated profit/(loss)		(3,438)		(3,438)	8		(3,430)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations	(29)			(29)	(7)		(36)
Total comprehensive income/(loss)	(29)	(3,438)		(3,467)	1		(3,466)
Issue of shares (net of costs)				3,919			3,919
Share-based payments				182			182
Released on forfeiture		7		-			-
	___ ______	___ ________	___ ______	___ _______	___ _______		___ _______
At 31 October 2017 (Unaudited)	103	(38,078)	(102)	10,159	(718)		9,441
For the period to 30 April 2018
Consolidated profit/(loss)		(4,118)		(4,118)	10		(4,108)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations	(117)			(117)	54		(63)
Total comprehensive income/(loss)				(4,235)	64		(4,171)
Issue of shares (net of costs)				10,472			10,472
Share-based payments				142			142
Released on forfeiture		67		-			-
	___ _______	___ _______	___ _______	___ _______	___ _______		___ _______
At 30 April 2018 (Audited)	(14)	(42,129)	(102)	16,538	(654)		15,884
For the period to 31 October 2018
Consolidated profit/(loss)		(4.258)		(4,258)	10		(4,248)
Other comprehensive income/(loss):
Exchange differences in translating foreign operations	190			190	(86)		104
Total comprehensive income/(loss)	190	(4,258)		(4,068)	(76)		(4,144)
Issue of shares (net of costs)				11,996			11,996
Share-based payments				125			125
Released on forfeiture		15		-			-
	___ ______	___ ________	___ ______	___ _______	___ _______		___ _______
At 31 October 2018 (Unaudited)	176	(46,372)	(102)	24,591	(730)		23,861
	=========	===========	==========	==========	==========	==========

ANGLE plc

NOTES TO THE INTERIM FINANCIAL INFORMATION

FOR THE SIX MONTHS ENDED 31 OCTOBER 2018

1       Basis of preparation and accounting policies

This Condensed Interim Financial Information is the unaudited interim consolidated financial information (the "Condensed Interim Financial Information") of ANGLE plc, a company incorporated in Great Britain and registered in England and Wales, and its subsidiaries (together referred to as the "Group") for the six month period ended 31 October 2018 (the "interim period").

The Condensed Interim Financial Information should be read in conjunction with the Financial Statements of the Group for the year ended 30 April 2018, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union (EU). New and revised IFRS and interpretations recently adopted by the EU and that became effective in the period, including IFRS 15, did not have or are not expected to have a significant impact on the Group. Where necessary, comparative information has been reclassified or expanded from the previously reported Condensed Interim Financial Information to take into account any presentational changes which were made in the Annual Report and Accounts 2018 and which may be made in the Annual Report and Accounts 2019.

The accounting policies used in the preparation of the Condensed Interim Financial Information for the six months ended 31 October 2018 are in accordance with the recognition and measurement criteria of IFRS, as adopted by the EU, and are consistent with those which will be adopted in the Financial Statements for the year ended 30 April 2019. While the Condensed Interim Financial Information has been prepared in accordance with the recognition and measurement criteria of IFRS, as adopted by the EU, these Financial Statements do not contain sufficient information to comply with IFRS.

This Condensed Interim Financial Information does not constitute statutory financial statements as defined in section 434 of the Companies Act 2006 and is unaudited and has not been reviewed.  The comparative information for the six months ended 31 October 2017 is also unaudited. The comparative figures for the year ended 30 April 2018 have been extracted from the Group Financial Statements as filed with the Registrar of Companies. The report of the auditors on those accounts was unqualified and did not contain statements under sections 498(2) or (3) of the Companies Act 2006.

The Condensed Interim Financial Information was approved by the Board and authorised for issue on 31 January 2019.

Going concern

The Financial Information has been prepared on a going concern basis which assumes that the Group will be able to continue its operations for the foreseeable future.

The Directors have prepared and reviewed financial projections for the 12 month period from the date of approval of this Condensed Interim Financial Information. Based on the level of existing cash and the projected income and expenditure (the timing of some of which is at the Group's discretion), the Directors have a reasonable expectation that the Company and Group have adequate resources to continue in business for the foreseeable future.  Accordingly the going concern basis has been used in preparing the Condensed Interim Financial Information.

       Critical accounting estimates and judgements

       The preparation of the Condensed Interim Financial Information requires the use of estimates, assumptions and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Information and the reported amounts of revenues and expenses during the reporting period.  Although these estimates, assumptions and judgements are based on the Directors' best knowledge of the amounts, events or actions, and are believed to be reasonable, actual results ultimately may differ from those estimates.

       The estimates, assumptions and judgements that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities relate to 1) the valuation and amortisation of internally generated intangible assets 2) impairment of intangible assets 3) share-based payments and 4) research and development tax credit.

2     Operating segment and revenue analysis

       The Group's principal trading activity is undertaken in relation to the commercialisation of its Parsortix cell separation system. The Group is also commercialising the HyCEAD Ziplex multiplex analysis system which is being used with the ovarian cancer clinical application and in other fields of use. The Directors believe that these activities comprise two operating segments. All significant decisions are made by the Board of Directors with implementation of those decisions on a Group-wide basis. The Group manages any overseas R&D and sales and marketing from the UK.

3       Tax

The Group undertakes research and development activities.  In the UK these activities qualify for tax relief resulting in research and development tax credits.

4       Earnings/(loss) per share

        The basic and diluted earnings/(loss) per share is calculated by dividing the after tax loss for the period attributable to the owners of the parent of £4.3 million (six months to 31 October 2017: loss £3.4 million, year to 30 April 2018: loss £7.6 million) by the weighted average number of shares in the period. 

        In accordance with IAS 33 Earnings per share 1) the "basic" weighted average number of ordinary shares calculation excludes shares held by the Employee Share Ownership Trust (ESOT) as these are treated as treasury shares and 2) the "diluted" weighted average number of ordinary shares calculation considers potentially dilutive ordinary shares from instruments that could be converted.  Share options are potentially dilutive where the exercise price is less than the average market price during the period.  Due to the losses in the periods, share options are non-dilutive for the respective periods as adding them would have the effect of reducing the loss per share and therefore the diluted loss per share is equal to the basic loss per share. 

        The basic and diluted earnings/(loss) per share are based on 129,580,872 weighted average ordinary 10p shares (six months to 31 October 2017: 74,920,311; year to 30 April 2018: 95,500,762). 

5       Intangible assets

	Goodwill	Acquired intangible assets	Intellectual property	Computer software	Product development	Total
	(Unaudited)	(Unaudited)	(Unaudited)	(Unaudited)	(Unaudited)	(Unaudited)
	£'000	£'000	£'000	£'000	£'000	£'000
Cost
At 1 May 2017 (Audited)	-	-	677	2	1,969	2,648
Additions	-	-	92	2	258	352
Exchange movements	-	-	(7)	-	(38)	(45)
	_________	_________	_________	_________	_________	_________
At 31 October 2017 (Unaudited)	-	-	762	4	2,189	2,955
Additions	-	-	54	3	242	299
Acquisition of assets	2,207	1,214	-	-	-	3,421
Disposals	-	-	-	(1)	-	(1)
Exchange movements	-	(1)	(7)	-	(52)	(60)
	_________	_________	_________	_________	_________	_________
At 30 April 2018 (Audited)	2,207	1,213	809	6	2,379	6,614
Additions	-	-	43	-	428	471
Exchange movements	-	6	17	-	111	134
	_________	_________	_________	_________	_________	_________
At 31 October 2018 (Unaudited)	2,207	1,219	869	6	2,918	7,219
	=======	=======	=======	=======	=======	=======
Amortisation and impairment
At 1 May 2017 (Audited)	-	-	164	-	566	730
Charge for the period	-	-	12	1	71	84
Exchange movements	-	-	(3)	-	(16)	(19)
	_________	_________	_________	_________	_________	_________
At 31 October 2017 (Unaudited)	-	-	173	1	621	795
Charge for the period	-	87	9	1	160	257
Disposals	-	-	-	(1)	-	(1)
Impairment	-	-	3	-	-	3
Exchange movements	-	-	(4)	-	(24)	(28)
	_________	_________	_________	_________	_________	_________
At 30 April 2018 (Audited)	-	87	181	1	757	1,026
Charge for the period	-	71	13	3	231	318
Exchange movements	-	2	10	-	66	78
	_________	_________	_________	_________	_________	_________
At 31 October 2018 (Unaudited)	-	160	204	4	1,054	1,422
	=======	=======	=======	=======	=======	=======
Net book value
At 31 October 2018 (Unaudited)	2,207	1,059	665	2	1,864	5,797
At 30 April 2018 (Audited)	2,207	1,126	628	5	1,622	5,588
At 31 October 2017 (Unaudited)	-	-	589	3	1,568	2,160

       "Goodwill" relates to the acquisition of the assets of Axela Inc. on 1 November 2017. Goodwill is deemed to have an indefinite useful life, is carried at fair value and is reviewed for impairment annually or more frequently if events or changes in circumstances indicate a potential impairment.

6       Share capital

The Company has one class of ordinary shares which carry no right to fixed income and at 31 October 2018 had 142,486,522 Ordinary shares of £0.10 each allotted, called up and fully paid.

During the period the Company issued 25,400,000 new ordinary shares with a nominal value of £0.10 at an issue price of £0.50 per share in a subscription of shares realising gross proceeds of £12.7 million. Shares were admitted to trading on AIM in late July and early August 2018. 

Post the reporting date, a further 1,000,000 new ordinary shares with a nominal value of £0.10 were issued in a share-for-share exchange with the original inventor of the Parsortix microfluidic technology such that ANGLE now owns 100 per cent of the US operating subsidiary ANGLE North America Inc. Shares were admitted to trading on AIM in November 2018.

7       Post reporting date events

As explained in the Chairman's Statement, subsequent to the reporting date the Company has made continued strong progress with Parsortix and made further announcements in relation to FDA clearance studies progress, ovarian cancer optimisation and breakthrough research in CTC clusters by a customer.

Shareholder communications

The announcement is being sent to all shareholders on the register at 31 January 2019.  Copies of this announcement are posted on the Company's website www.ANGLEplc.com and are available from the Company's registered office: 10 Nugent Road, Surrey Research Park, Guildford, Surrey, GU2 7AF.

 

END

 

 

IR LIFLILVILVIA