VolitionRx — 13,500-person prospective US trial on deck

VolitionRx (NYSE: VNRX)

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VolitionRx — 13,500-person prospective US trial on deck

VolitionRx will be participating in a 13,500-patient prospective trial investigating its colorectal Nu.Q™ test (and other biomarkers) in the US. The trial will be run in collaboration with the National Cancer Institute (NCI) and the University of Michigan, which will be bearing the majority of its cost. VolitionRx will only pay $3m over the two to three years the trial is expected to take to complete. We are reducing our valuation to $236m (from $272m) or $8.89 per basic share due to the long timeline in the US.

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Healthcare

VolitionRx

13,500-person prospective US trial on deck

Earnings update

Healthcare equipment
& services

21 August 2017

Price

US$2.52

Market cap

US$67m

Net cash ($m) at 30 June 2017

15.3

Shares in issue

26.6m

Free float

73.4%

Code

VNRX

Primary exchange

NYSE American

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(22.2)

(25.9)

(28.2)

Rel (local)

(21.1)

(27.7)

(35.3)

52-week high/low

US$5.6

US$2.5

Business description

VolitionRx is a diagnostics company focused on developing blood-based cancer diagnostics using its proprietary Nu.Q™ technology. Its lead program is in colorectal cancer, which is being advanced for both triage and frontline testing in Europe and the US.

Next events

Danish CRC screening steering committee meeting

September 2017

Analysts

Nathaniel Calloway

+1 646 653 7036

Maxim Jacobs

+1 646 653 7027

VolitionRx is a research client of Edison Investment Research Limited

VolitionRx will be participating in a 13,500-patient prospective trial investigating its colorectal Nu.Q™ test (and other biomarkers) in the US. The trial will be run in collaboration with the National Cancer Institute (NCI) and the University of Michigan, which will be bearing the majority of its cost. VolitionRx will only pay $3m over the two to three years the trial is expected to take to complete. We are reducing our valuation to $236m (from $272m) or $8.89 per basic share due to the long timeline in the US.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
(c)

P/E
(x)

Yield
(%)

12/15

0.0

(9.7)

(0.54)

0.0

N/A

N/A

12/16

0.0

(12.3)

(0.53)

0.0

N/A

N/A

12/17e

0.0

(13.7)

(0.51)

0.0

N/A

N/A

12/18e

1.3

(18.5)

(0.67)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments.

US trial to support PMA filing

For the US trial, 4,677 samples have already been collected and up to an additional 9,000 samples will be prospectively collected from asymptomatic individuals aged 50 years and over. At this scale, this is one of the largest ever trials for a colorectal cancer screening product. After feedback from the FDA, Exact Sciences ran a 10,000-person prospective clinical trial. VolitionRx has stated that it believes its trial should support a PMA, although it has not confirmed this with the FDA.

Trial to be run by experienced biomarker researchers

The US trial will be run by the Great Lakes New England (GLNE) Clinical Validation Center at the University of Michigan. The NCI established these centers to test the clinical utility of biomarkers for the detection of cancer, and the GLNE has significant experience in performing large colorectal cancer screening trials. It previously performed the independent validation study of Cologuard with 6,000 patients and has published over 30 papers on its findings on cancer biomarkers.

Moving forward with the triage test in Asia

VolitionRx announced in its Q217 earnings report that it has initiated the regulatory process in both Singapore and Taiwan for approval of the Nu.Q™ colorectal cancer screening triage test, and that trials are ongoing in Taiwan. Both of these countries have national screening networks that could utilize the test. Also, approval in Singapore would provide access to the nine other ASEAN markets (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand and Vietnam).

Valuation: Lowered to $236m or $8.89 per basic share

We have lowered our valuation to $236m or $8.89 per basic share, from $272m or $10.32 per basic share. This is driven by a longer timeline for approval of the colorectal test for the US, which we now expect to enter the market in 2022. This has also increased our financing requirement to $67m (from $45m) due to the delay in profitability to 2022 (from 2021).

Big US trial for frontline colorectal test

In July 2017, VolitionRx announced that it will be participating in a 13,500-person trial in the US investigating biomarkers for colorectal cancer screening. The Nu.Q™ colorectal screening test will be incorporated into the panel, and the company has stated that it believes the data from this study should be sufficient to support US PMA approval, although it has not met with the FDA to delineate the actual approval requirements. 4,677 samples have already been collected for the study and up to an additional 9,000 samples will be prospectively collected from asymptomatic individuals 50 years and over who have not undergone a colonoscopy. The study is being run in collaboration with the National Cancer Institute's (NCI) Early Detection Research Network (EDRN) and the Great Lakes New England (GLNE, of the University of Michigan) Clinical Validation Center and is expected to take two to three years to complete.

A positive aspect of this clinical trial plan is the cost savings to VolitionRx. The company has committed only $3m to the collaboration expenses. This is exceptionally inexpensive considering the size and scope of the trial. This will be one of the largest clinical studies to support the approval of a colorectal cancer screening product. The stool-screening test, Cologuard (Exact Sciences), was approved using the data from a 10,000-person prospective trial.

The precise details of the clinical program have not been announced yet. However, GLNE, which will be performing the trial, is highly experienced at similar large colorectal biomarker screening projects. It previous performed validation testing on Cologuard (along with other biomarkers) in a 6,000-person study. The center has published over 30 papers based on research from its biomarker clinical trials.

We expect the FDA to evaluate data from this trial similarly to the pivotal trial for Cologuard. This study had primary endpoints that the lower bound of the 95% confidence interval for sensitivity exceed 65% for colorectal cancer and exceed 85% specificity for advanced neoplasias.

Exhibit 1: CRC screening technology comparison

Sensitivity (%)

False negative rate (%)

Specificity (%)

False positive rate (%)

Cost per test ($)

Number of tests in US annually (m)

Negatives

Colonoscopy

95

5

95

5

1,000-3,000

4.3

Invasive, adverse events, cost

FOBT

50

50

98

2

5

5.6

Fecal-based test, high false negative, accuracy depends on which specific FOBT variant used

FIT

68

32

97.4

2.6

23

4.6

Fecal-based test, high false negative

Cologuard

(Exact Sciences)

92

8

87

13

428

0.55*

Fecal-based test, high cost

Epi proColon (Epigenomics)

72

28

81

19

141

small

Blood based

Nu.Q™ (VolitionRx)

81-91

9-19

78-90

10-22

40-80

N/A

Blood based, low cost

Source: FDA, World Gastroenterology Organisation, Exact Sciences, VolitionRx. Note: *2017 guidance. FOBT=fecal occult blood test; FIT=fecal immunochemical test.

In other news

VolitionRx announced on 27 June 2017 that it would be replacing some of the immunoassays present in its Nu.Q™ colorectal cancer screening triage test. This decision followed reanalysis of the data from the 8,000-person clinical trial of the test announced in May 2017. Certain immunoassays in the test had high p-values, and the company is replacing them. The redesign of the panel will necessitate an updated or new CE mark, which will take a few months. This process may affect the upcoming decision from the Danish colorectal cancer screening steering committee, which is planned to meet in September 2017. If the test does not have a CE mark at this time, it may affect the committee’s decision to adopt it or not. Additionally, it is unclear at this time to what degree data from the previous version of the test can be used to support the approval of the new test.

The company also announced that it had initiated the process of seeking approval in Taiwan and Singapore. The regulatory process has been initiated in both locations. An approval in Singapore would allow the test to be marketed into the nine other markets that are part of ASEAN with a total population of 625 million people, although we should note that national screening programs are not widespread. The triage test has entered the clinic in Taiwan. Both of these countries have nationalized screening programs that employ the FIT test as a first-line screen, and are therefore ideal target markets.

Finally, the company announced that it has opened a new research facility in Belgium, which will increase the R&D capacity of the company. This will enable increased development into other indications, such as prostate, lung, and pancreatic cancer tests.

Valuation

We have lowered our valuation to $236m or $8.89 per basic share, from $272m or $10.32 per basic share. We have reduced our valuation for the frontline Nu.Q™ colorectal screening test to $148m (from $170m) based on the timeline for the pivotal US trial, which has delayed our US launch date to 2022. We previously modelled that the company would pursue approval initially though a 510(k) pathway with early albeit more limited sales in 2018. We should note that although the company believes that the US trial will support a PMA, it has not confirmed this with the FDA, and any changes to the development plan may result in further delays.

We have also reduced the valuation for the Nu.Q™ colorectal cancer screening triage test to $21m from $29m. This adjustment was made to account for the redesign of the test, which we believe will result in delays of initial revenue from 2017 to 2018. This will have little impact on near-term cash flow, as this revenue was small, but will delay the eventually acceptance of the test by European screening programs and the sales ramp. We have also delayed the launch of the Nu.Q™ lung and pancreatic test to 2019 based on lack of advancement in these programs. Other adjustments to our valuation include lower net cash ($15.3m from $17.7m), and rolling forward our NPVs to the most recent quarter. We have not added Asian markets to our valuation until we have an understanding of the company’s commercialization plan in this region.

Exhibit 2: Valuation

Product

Main indication

Status

Prob. of commercial success

Launch year

Peak sales ($m)

Patent protection

Economics

rNPV ($m)

Nu.Q™

Colorectal

Development

30%

2018

$404

2034

56% peak margin

$148

 

Colorectal triage

Development

50%

2018

$42

2034

50% peak margin

$21

 

Lung

Development

30%

2019

$145

2034

61% peak margin

$42

Pancreatic

Development

30%

2019

$37

2034

58% peak margin

$10

Total

 

 

 

 

 

 

 

$221

Cash and cash equivalents (Q217) ($m)

$15.3

Total firm value ($m)

$236

Total basic shares (m)

26.5

Value per basic share ($)

$8.89

Warrants and options (m)

4.9

Weighted average exercise price ($)

$3.45

Cash on exercise ($m)

$16.9

Total firm value ($m)

$253

Total number of shares (m)

31.4

Diluted value per share ($)

$8.04

Source: Edison Investment Research, VolitionRx reports

Financials

VolitionRx reported a loss from operations of $3.5m for Q217, which is a slight increase over the previous period ($3.4m). Spending was roughly split evenly between G&A and R&D. Our projections for R&D spending for 2017 have been reduced by $1m as we have shifted spending to support the 13,500-person US trial into later years. The company ended the quarter with $15.3m in net cash. Due to the longer timeframe for approval in the US, we now expect that the company will reach profitability in 2022 (from 2021) and will require $67m (modeled as $15m in illustrative debt in each of 2017, 2018 and 2019, and $22m in 2020) in additional financing (from $45m).

Exhibit 3: Financial summary

$000s

2015

2016

2017e

2018e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

0

0

0

1,332

Cost of Sales

0

0

0

(166)

Gross Profit

0

0

0

1,166

Research & Development

(6,102)

(6,838)

(7,521)

(8,273)

Sales, General & Administrative

(3,904)

(5,429)

(6,131)

(10,213)

EBITDA

 

 

(10,006)

(12,267)

(13,652)

(17,320)

Operating Profit (before amort. and except.)

(10,006)

(12,267)

(13,652)

(17,320)

Intangible Amortization

0

0

0

0

Other

0

0

0

0

Exceptionals

0

0

0

0

Operating Profit

(10,006)

(12,267)

(13,652)

(17,320)

Net Interest

0

0

0

(1,165)

Other

471

252

93

0

Profit Before Tax (norm)

 

 

(9,666)

(12,267)

(13,652)

(18,485)

Profit Before Tax (FRS 3)

 

 

(9,535)

(12,014)

(13,559)

(18,485)

Tax

5

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(9,661)

(12,267)

(13,652)

(18,485)

Profit After Tax (FRS 3)

(9,530)

(12,014)

(13,559)

(18,485)

Average Number of Shares Outstanding (m)

17.7

23.0

26.7

27.7

EPS - normalised (c)

 

 

(54.49)

(53.22)

(51.23)

(66.69)

EPS - FRS 3 ($)

 

 

(0.54)

(0.52)

(0.51)

(0.67)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,489

2,721

3,735

2,996

Intangible Assets

705

602

599

599

Tangible Assets

784

2,119

3,136

2,397

Other

(0)

(0)

(0)

(0)

Current Assets

 

 

6,070

21,846

26,480

26,906

Stocks

0

0

0

8

Debtors

0

0

0

237

Cash

5,916

21,679

26,333

26,514

Other

154

167

147

147

Current Liabilities

 

 

(1,120)

(2,033)

(2,352)

(3,030)

Creditors

(1,120)

(2,003)

(2,214)

(2,892)

Short term borrowings

0

(31)

(138)

(138)

Long Term Liabilities

 

 

(548)

(1,524)

(17,145)

(32,145)

Long term borrowings

0

(432)

(16,065)

(31,065)

Other long term liabilities

(548)

(1,092)

(1,080)

(1,080)

Net Assets

 

 

5,891

21,009

10,718

(5,273)

CASH FLOW

Operating Cash Flow

 

 

(8,766)

(9,056)

(10,655)

(14,806)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(352)

(415)

(1,235)

(13)

Acquisitions/disposals

0

0

0

0

Financing

12,498

25,302

879

0

Dividends

0

0

0

0

Other

0

(553)

(61)

0

Net Cash Flow

3,379

15,279

(11,072)

(14,819)

Opening net debt/(cash)

 

 

(2,139)

(5,916)

(21,216)

(10,131)

HP finance leases initiated

0

0

0

0

Exchange rate movements

13

146

(100)

0

Other

385

(125)

87

0

Closing net debt/(cash)

 

 

(5,916)

(21,216)

(10,131)

4,688

Source: Edison Investment Research, VolitionRx reports

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by VolitionRx and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
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Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by VolitionRx and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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