VolitionRx — Nu.Q lung cancer test development accelerates

VolitionRx (NYSE: VNRX)

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Research: Healthcare

VolitionRx — Nu.Q lung cancer test development accelerates

The main highlights of VolitionRx’s Q219 results were the establishment of a veterinary subsidiary in Texas, US and the initiation of two lung cancer trials; the first in collaboration with Fosun Long March in China and the second with National Taiwan University. This indicates that lung cancer is gaining traction in R&D and is now the second most advanced indication after colorectal cancer. In July 2019 VolitionRx exercised warrants to raise another $4.8m (ytd it has exercised $16.5m), extending the cash runway to 2021. Our valuation post the warrant exercise is $226m or $5.50/share.

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Written by

Healthcare

VolitionRx

Nu.Q lung cancer test development accelerates

Q219 results

Pharma & biotech

21 August 2019

Price

US$4.10

Market cap

US$169m

Net cash ($m) at end Q219 + $4.8m from warrant exercise post Q219

20.8

Shares in issue

41.1m

Free float

70%

Code

VNRX

Primary exchange

NYSE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

17.1

25.0

133.0

Rel (local)

20.2

22.4

129.5

52-week high/low

US$4.47

US$1.70

Business description

VolitionRx is a life sciences company developing novel, simple-to-use, blood-based tests to diagnose a range of cancers and conditions by identifying and measuring nucleosomes in the blood stream. The primary focus is to develop the Nu.Q family of blood-based diagnostics tests for cancer.

Next events

Proof-of-concept data in various indications with product-grade assays

2019

Updates on the studies run in partnership with the National Taiwan University

2019

Update on the collaboration with the Texas A&M university in animal health

2019

Update on the progress of collaborations with Fosun Long March

2019

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

The main highlights of VolitionRx’s Q219 results were the establishment of a veterinary subsidiary in Texas, US and the initiation of two lung cancer trials; the first in collaboration with Fosun Long March in China and the second with National Taiwan University. This indicates that lung cancer is gaining traction in R&D and is now the second most advanced indication after colorectal cancer. In July 2019 VolitionRx exercised warrants to raise another $4.8m (ytd it has exercised $16.5m), extending the cash runway to 2021. Our valuation post the warrant exercise is $226m or $5.50/share.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/17

0.0

(15.1)

(0.57)

0.0

N/A

N/A

12/18

0.0

(18.0)

(0.49)

0.0

N/A

N/A

12/19e

0.1

(18.3)

(0.45)

0.0

N/A

N/A

12/20e

0.1

(19.7)

(0.47)

0.0

N/A

N/A

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

Fosun collaboration and progress in animal heath

On 18 July 2019, VolitionRx announced that it had started a clinical trial in China in lung cancer in partnership with Fosun Long March, which is owned by conglomerate, Shanghai Fosun Pharmaceutical. Fosun Long March is an in-vitro diagnostics company active in the R&D, manufacture and marketing of diagnostic and laboratory instruments and reagents, so it is a suitable partner for Volition. Financial details were not disclosed. VolitionRx already has a presence in Asia via an R&D collaboration with the National Taiwan University and the parties are running a large-scale, prospective study in lung cancer (blood samples from 1,200 subjects). These developments mean that lung cancer has become central to VolitionRx’s product development strategy in addition to colorectal cancer.

New subsidiary established

On 8 August 2019, VolitionRx announced the formation of a subsidiary, Volition Veterinary Diagnostics Development based in Texas, US. A separate subsidiary was deemed as the best corporate structure to explore opportunities in animal health. Although a relatively new area, VolitionRx presented its plans to expand in the veterinary space at the capital markets day in April 2019. Animal health could potentially be a commercially lucrative area given the size of the market, the high unmet need and the lower regulatory hurdle compared with humans.

Valuation: $226m or $5.50/share

Our VolitionRx absolute valuation is somewhat higher at $226m (vs $215m) due to an updated cash position and rolling the model forward, while the valuation per share is virtually unchanged at $5.50 (vs 5.46) due to dilution post the warrant issue. We made no changes to our estimates. Newsflow over the next 12 months includes more proof-of-concept data with the product grade assays, initial results from the Asian clinical trials, progress in colorectal cancer test development and updates on the animal health venture.

VolitionRx is a research client of Edison Investment Research Limited

R&D update

Nu.Q lung cancer test development accelerates

The main highlights of the Q219 results were the establishment of a subsidiary in Texas, US and the initiation of two lung cancer trials; the first in collaboration with Fosun Long March in China and the second with National Taiwan University. The signing of a memorandum of understanding with Fosun Long March was announced on 28 March 2019. The preliminary plan was to conduct clinical studies in China to investigate several solid cancers. On 18 July 2019, VolitionRx announced that the parties have commenced a clinical trial in China in lung cancer. Financial details have not been disclosed.

As we described in our outlook report in May, VolitionRx already had a presence in Asia via an R&D collaboration with the National Taiwan University. On 7 May 2019, VolitionRx announced the first (at that time) large-scale, prospective study in lung cancer (blood samples from 1,200 subjects). The aim of the study is to develop either a frontline screening test in lung cancer or a triage test after low-dose computed tomography (LDCT) (gold standard currently) to address the low specificity associated with LDCT. The total cost for VolitionRx was estimated at $320k over the next two years (until 2021). The first data readout is expected in Q120.

Historically, VolitionRx’s primary focus has been colorectal cancer, so we presume the interest in lung cancer is largely driven by the Chinese partner. We view this as a strategic opportunity for VolitionRx to access the Chinese market, but also to advance the second cancer indication in its R&D pipeline. To this end, VolitionRx presented the first proof-of-concept data from its own exploratory study in lung cancer using the product-grade assays earlier this year (described in our recent outlook report).

Texas subsidiary to focus on animal health opportunity

On 8 August 2019, VolitionRx announced the formation of a subsidiary, Volition Veterinary Diagnostics Development, based in Texas, US. Animal health expert Nathan Dewsbury has been appointed chief executive officer. A separate subsidiary was deemed to be the best corporate structure for VolitionRx to explore opportunities in animal health, as the company indicated that it would be open for interested partners to take equity stakes in it. The current collaborator, Texas A&M University, has previously expressed an interest in such an investment, but we understand that for now the subsidiary is wholly owned by VolitionRx.

Although a relatively new area, VolitionRx presented its plans to expand in the veterinary space at the capital markets day in April 2019. The feasibility studies showed that using the same assays as in humans, the researchers were able to detect nucleosomes in samples from dogs diagnosed with cancer. Animal health has the potential to be a commercially lucrative area due to the combination of a large market, high unmet need and a substantially lower regulatory hurdle compared with humans. VolitionRx indicated that the first product for dog cancer diagnostics could be ready for market as soon as 2020. Due to the early stage of the product at present, we do not include it in our valuation, but will revisit once more information is available.

Financials and valuation

VolitionRx reported no income and an operating loss of $4.1m in Q219, compared to $4.6m a year ago, which is largely in line with our expectations. The company had cash of $18.5m at end-Q219. After the Q219 close, the company exercised a further $4.8m in warrants. In total, VolitionRx has exercised $16.5m in warrants in 2019 showing investor support. VolitionRx had $2.5m in gross debt and $1.0m in lease liabilities at the end of Q219. Assuming a similar level of cash burn, our model now suggests cash runway until the end of 2020 (our model suggests a shortfall of $1.8m, which we add as a long-term debt).

Our VolitionRx absolute valuation is somewhat higher at $226m (previously $215m) due to the updated cash position and rolling our model forward, while the valuation per share is virtually unchanged at $5.50 (vs 5.46) due to dilution post the warrant issue. Our other R&D assumptions, detailed in our previous notes, remain unchanged.

VolitionRx is conducting multiple proof-of-concept studies with the upgraded Nu.Q assays, as described in detail in our last outlook report and summarised on Exhibit 2. The results from those studies, although early, could provide interesting catalysts for the share price. Of the larger programmes (Exhibit 3), VolitionRx has indicated that the interim readout from the lung cancer trial in Asia is expected in Q120. For now we still do not include Nu.Q Vet or Nu.Q Capture commercial potential in our valuation due to early stage of these programmes and lack of details. However, there is potential for the Nu.Q Vet programme to progress relatively quickly compared to cancer diagnostics in humans due to the lower R&D hurdles in animal health.

Exhibit 1: Valuation of VolitionRx

Product

Main Indication

Status

Prob. of commercial success

Launch year

Peak sales ($m)

Patent protection

Economics

rNPV ($m)

NuQ

Colorectal

Development

30%

2021

$404

2034

56% peak margin

$156

 

Colorectal triage

Development

40%

2021

$42

2034

50% peak margin

$10

 

Lung

Development

20%

2022

$132

2034

61% peak margin

$29

Pancreatic

Development

20%

2022

$42

2034

58% peak margin

$6

Total

 

 

 

 

$202

Cash and cash equivalents (Q219) + $4.8m after warrant exercise ($m)

$23.3

Total firm value ($m)

$226

Total number of basic shares (m)

41.1

Value per basic share ($)

$5.50

Warrants and options (m)

6.0

Weighted average exercise price ($)

$3.70

Cash on exercise ($m)

$22.3

Total firm value (fully diluted) ($m)

$248

Total number of shares (fully diluted)

47.1

Value per share (fully diluted) ($)

$5.27

Source: Edison Investment Research, VolitionRx reports

Exhibit 2: VolitionRx proof-of-concept studies with product-grade assays

Indication

Sample cohort

Expected

Indication

Sample cohort

Expected

Colorectal cancer

225

Q219

Prostate cancer

120

H119

Colorectal cancer

552

H119

Prostate cancer

100

H219

Colorectal cancer

352

H219

Pancreatic cancer

100

H219

Lung cancer

76

Q119

Head and neck cancer

200

H219

Lung cancer

152

H119

Endometriosis

10 (x 5 collections)

H219

Endometriosis

300

H219

Source: VolitionRx

Exhibit 3: VolitionRx blood sample bank

Indication

Sponsor

Patients

Notes

Colorectal cancer

NCI Early Detection Research Network

9,000 prospective
4,600 retrospective

Frontline screening. Main programme in the US; collection ongoing to 2020.

Colorectal cancer

National Taiwan University

5,000 prospective

Frontline screening; collection ongoing to 2021.

Colorectal cancer

National Taiwan University

2,000 prospective

Diagnostic test in symptomatic patients; collection ongoing to 2021.

Colorectal cancer

Hvidovre Hospital (Denmark)

14,000+ prospective

Screening population. Collection complete and analysis ongoing.

Colorectal cancer

Hvidovre Hospital (Denmark)

30,000 prospective

Screening population. Collection complete and analysis ongoing.

Colorectal cancer

Hvidovre Hospital (Denmark)

4,800 retrospective

Diagnostic test in symptomatic patients. Collection complete and analysis ongoing.

Lung cancer

National Taiwan University

1,200 prospective

Collection expected to start in mid-2019 to 2021.

Pancreatic cancer

German Cancer Research Center (DKFZ)

750 retrospective

Collection complete and analysis ongoing.

27 most prevalent cancers

Bonn University Hospital (Germany)

4,500 prospective

Broad, prospective screen of 27 most prevalent cancers to identify differences in nucleosome modification. Collection complete and analysis ongoing.

Source: VolitionRx

Exhibit 4: Financial summary

$'000s

2017

2018

2019e

2020e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

0

0

50

100

Cost of Sales

0

0

0

0

Gross Profit

0

0

50

100

Research & Development

(8,906)

(10,907)

(10,561)

(11,195)

Sales, General & Administrative

(6,140)

(6,991)

(7,690)

(8,459)

EBITDA

 

 

(15,046)

(17,898)

(18,201)

(19,554)

Operating profit (before amort. and except.)

 

 

(15,046)

(17,898)

(18,201)

(19,554)

Intangible Amortisation

0

0

0

0

Other

0

0

0

0

Exceptionals

0

0

0

0

Operating Profit

(15,046)

(17,898)

(18,201)

(19,554)

Net Interest

(73)

(111)

(125)

(117)

Other

414

0

0

0

Profit Before Tax (norm)

 

 

(15,119)

(18,009)

(18,326)

(19,671)

Profit Before Tax (FRS 3)

 

 

(14,705)

(18,009)

(18,326)

(19,671)

Tax

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(15,119)

(18,009)

(18,326)

(19,671)

Profit After Tax (FRS 3)

(14,705)

(18,009)

(18,326)

(19,671)

Average Number of Shares Outstanding (m)

26.4

37.0

40.3

41.9

EPS - normalised ($)

 

 

(0.57)

(0.49)

(0.45)

(0.47)

EPS - FRS 3 ($)

 

 

(0.56)

(0.49)

(0.45)

(0.47)

Dividend per share ($)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

4,057

3,587

2,838

2,269

Intangible Assets

576

467

467

467

Tangible Assets

3,481

3,120

2,371

1,802

Other

(0)

0

(0)

(0)

Current Assets

 

 

10,319

13,657

15,060

353

Stocks

0

0

0

0

Debtors

0

0

(91)

18

Cash

10,116

13,427

14,921

105

Other

202

230

230

230

Current Liabilities

 

 

(2,290)

(2,333)

(2,283)

(2,308)

Creditors

(1,847)

(1,917)

(1,867)

(1,892)

Short term borrowings

(444)

(417)

(417)

(417)

Long Term Liabilities

 

 

(2,376)

(3,015)

(3,015)

(4,815)

Long term borrowings

(1,313)

(1,984)

(1,984)

(3,784)

Other long term liabilities

(1,063)

(1,031)

(1,031)

(1,031)

Net Assets

 

 

9,709

11,895

12,599

(4,502)

CASH FLOW

Operating Cash Flow

 

 

(12,193)

(14,733)

(14,966)

(16,616)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(1,425)

(302)

0

0

Acquisitions/disposals

0

0

0

0

Financing

998

17,245

16,461

0

Dividends

0

0

0

0

Other

(136)

(138)

0

0

Net Cash Flow

(12,756)

2,073

1,494

(16,616)

Opening net debt/(cash)

 

 

(21,216)

(8,360)

(11,026)

(12,520)

HP finance leases initiated

0

0

0

0

Exchange rate movements

(89)

(379)

0

0

Other

(12)

973

0

0

Closing net debt/(cash)

 

 

(8,360)

(11,026)

(12,521)

4,096

Source: Company data, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by VolitionRx and prepared and issued by Edison, in consideration of a fee payable by VolitionRx. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

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General disclaimer and copyright

This report has been commissioned by VolitionRx and prepared and issued by Edison, in consideration of a fee payable by VolitionRx. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

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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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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Target Healthcare REIT — Continuing positive returns in Q4

Target’s portfolio of high-quality purpose-built care homes continues to grow and perform well with RPI-driven rental growth, increased property valuations, continuing acquisitions of operational homes and progress with pre-let forward-funded developments. Due diligence on potential further acquisition opportunities continues, in aggregate sufficient to fully deploy remaining debt capital resources.

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