VolitionRx — Update 23 September 2016

VolitionRx (NYSE: VNRX)

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VolitionRx — Update 23 September 2016

VolitionRx

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Healthcare

VolitionRx

First product ready to enter market

Company outlook

Healthcare equipment
& services

23 September 2016

Price

US$4.88

Market cap

US$115m

Net cash ($m) at Q216

14.5

Shares in issue

23.5m

Free float

72%

Code

VNRX

Primary exchange

NYSE MKT

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

35.9

46.1

0.8

Rel (local)

36.3

40.0

(10)

52-week high/low

US$5.2

US$3.1

Business description

VolitionRx is a diagnostics company focused on developing blood-based cancer diagnostics using its proprietary NuQ technology. Its lead program is in colorectal cancer, which may enter the European market in 2017.

Next events

ESMO presentation of triage test data

October 2016

Additional CRC data

H216

FDA feedback on 510(k) pathway

H117

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

VolitionRx is a research client of Edison Investment Research Limited

VolitionRx is a developer of blood-based diagnostics for cancer that detect the quantity and composition of cell-free nucleosomes (a complex of protein and DNA) present in the blood. The company announced its first commercial product, the NuQ triage colorectal cancer test, will launch in select European countries in early 2017. The product is not a diagnostic test, but is designed to reduce the number of colonoscopies by screening false positives from fecal immunochemical tests (FIT).

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/14

0.0

(8.4)

(0.62)

0.0

N/A

N/A

12/15

0.0

(9.7)

(0.54)

0.0

N/A

N/A

12/16e

0.0

(15.1)

(0.67)

0.0

N/A

N/A

12/17e

1.4

(16.8)

(0.72)

0.0

N/A

N/A

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

Triage test to be marketed for European screening

Of the 28 EU member states, 14 have established colorectal cancer screening programs, most based on FIT testing. However, the number of false positive FITs is substantial and unnecessary colonoscopies are a burden on the medical system. The NuQ triage test will be used after a positive FIT test to rule out unnecessary colonoscopies, up to 25% based on company estimates. The company will be marketing the test directly to these European central health authorities.

Increasing clinical data support

In the past year, the amount of clinical data supporting the utility of nucleosomes for the detection of cancer, and the NuQ tests, have substantially increased. The first prospective colorectal trial reported 91% sensitivity and 90% specificity. A test optimized for adenomas detected 75%, best in class for non-invasive tests. NuQ outperformed the prostate specific antigen (PSA) test for prostate cancer. Also, a prospective study identified 93% of lung cancer patients with 91% specificity.

At least five readouts in next nine months

The company is engaged in eight clinical programs, five of which are expected to have a data readout in the next nine months. These include interim data on the 14,000-patient colorectal screening trial, as well as pilot studies for endometriosis, pancreatic cancer and prostate cancer. Finally, the results from the first prospective lung cancer trial will be released, which could potentially make this the next indication (after colorectal) for which the company will be seeking approval.

Valuation: $246m or $10.46 per basic share

We have increased our valuation to $246m or $10.46 per basic share, from $231m or $10.00 per basic share. The increase is due to rolling our NPVs forward to Q316. The addition of the colorectal triage test (value of $12m) is largely offset by a delay in our expected commercialization timing for the frontline test in Europe ($11m). We expect the company to need $60m in additional capital before 2021.

Investment summary

Company description: Blood-based cancer diagnostics

VolitionRx is developing the NuQ cell free nucleosome test for the blood-based detection of a series of different cancers. The test detects the fragments of chromosomes that are released on cancer cell death and uses the modifications present on these structures to rule out other diseases. This provides a non-invasive method of detecting cancer, and because the technology is based on the routine ELISA test, it is easily integrated into existing protocols at a low cost ($20-50). The lead program is for the detection of colorectal cancer (CRC), a market with 225 million people in the US and Europe. The company will begin commercialization of its first test in Europe starting in early 2017. US commercialization will proceed in stages with first a 510(k) approval followed by additional trials and an eventual PMA. First US sales are expected in late 2017 or early 2018.

Valuation: $246m or $10.46 per basic share

We have increased our valuation to $246m or $10.46 per basic share, from $231m or $10.00 per basic share, primarily due to rolling over our NPVs. We currently record CRC (including triage test, and US and EU frontline tests) as the most valuable program at $182m, and the majority of this value ($112m) is from US commercialization. This assumes a 33% peak market share and 20% compliance of the predicted screening population to blood tests. We predict initial pricing in the US of $40 and $20 in Europe. We expect to update our valuation with the release of additional clinical data over the next nine months, and on the release of the parameters of the NuQ triage colorectal test at the European Society for Medical Oncology (ESMO) in October 2016. We currently value the lung and pancreatic cancer programs at $40m and $9m respectively.

Financials: $60m needed before profit

The company ended Q216 with $14.5m in cash after losses of $2.9m for the quarter. We expect an increase in both R&D and SG&A costs associated with the trials needed for marketing approval for the frontline test and the commercial launch of the triage test and forecast $15m in pre-tax losses for 2016 and $17m for 2017. We predict that the company will need an additional $60m in financing before profitability in 2021 with acceptance of a PMA for the test in the US.

Sensitivities: First revenue soon but not in the clear

The risks to the company are typical of small diagnostics companies and are a combination of clinical development risks and commercial uncertainties. The majority of studies of the NuQ technology have been retrospective and prospective trials have been small. The company will need to perform large prospective trials to receive marketing approval. Moreover, the specificity demonstrated in these various studies has been low enough (low 90% range) that high number of false positives would be expected for these tests. This is a problem identified by the FDA, although the recent approval of Epi proColon on the basis of improving compliance over FIT is seen as a positive regulatory sign. The market for the lung and prostate cancer screening is small in comparison to colorectal screening as they are limited to a subset of smokers and to first-degree relatives of cancer victims respectively. The market for the colorectal triage test is also small because it only follows a positive FIT test, which occurs in 7% of those tested. We expect the triage test commercial launch to be slow due to the need to negotiate with multiple central health committees across Europe. Revenue from this early market entry will offset the funding requirement to reach profitability, but the amount is still substantial at $60m.


A common marker for cancer

VolitionRx is a diagnostics company developing blood-based cancer diagnostics. Its NuQ tests are a series of assays designed to quantify cell free nucleosomes in the blood as well as any mutations or modifications of those nucleosomes. Nucleosomes are a combination of DNA and protein that are normally found in chromosomes, but in distressed or dying cells they become free and are released into the bloodstream. In healthy cells, nucleosomes are modified to control the expression of different genes, but in cancer nucleosomes become hyper-modified as the cell loses the ability to regulate normal gene expression. NuQ tests measure both the number of cell free nucleosomes and their modification, and a typical panel of test for a particular cancer type uses four to five different NuQ assays against different nucleosome modifications to improve the predictive power. NuQ tests use the widespread ELISA testing technology, and therefore can be easily integrated into pre-existing testing protocols and infrastructure. The company’s lead program is a test for CRC, but it is also developing tests for lung, pancreatic and prostate cancer.

Exhibit 1: VolitionRx clinical programs

Indication

Sponsor

Patients

Data

Notes

Colorectal cancer

Hvidovre Hospital (Denmark)

4,800

H216 or H117

Biomarker analysis to differentiate polyps adenomas, cancer, and other bowel disease

Colorectal cancer

Hvidovre Hospital (Denmark)

14,000

H216 or H117

All subjects will have a FIT test ; those who test positive will have a colonoscopy

27 most prevalent cancers

Bonn University Hospital (Germany)

4,700

H117

Broad screen of 27 most prevalent cancers to identify differences in nucleosome modification

Lung cancer

Center Hospitalier Universitaire de Liege (Belgium)

600

H117

Prospective study to evaluate NuQ for early detection of lung cancer

Pancreatic cancer

German Cancer Research Center (DKFZ) (Germany)

750

Q117

750-patient study to detect pancreatic cancer

Prostate cancer

MD Anderson Cancer Center (US)

TBD

H117

Pilot study to detect anaplastic prostate cancer, a severe subtype

Prostate cancer

ImmuneHealth (Belgium)

120

Q117

Multicenter study to evaluate ability of NuQ to detect prostate cancer

Endometriosis

The University of Oxford (England)

500

H117

Pilot study

Source: VolitionRx

Colorectal cancer

The company’s lead program is developing a series of tests for CRC. The strategy is multi-tiered with separate specialized plans for the US and European roll-outs. The company will be commercializing initially in Europe with the recently announced (September 2016) triage test strategy, a test targeting reducing colonoscopies within the scope of pre-existing state run CRC testing programs (see below). The triage test will begin commercialization in early 2017. Initial commercialization in the US will consist of a 510(k) approved test to be used as an adjunct to established CRC diagnoses, with an expected launch in late 2017 or early 2018. Following these initial entries into the market, the company will continue to develop and launch first-line diagnostic tests with the goal of providing a definitive diagnosis of CRC. These test aim to act as a replacement for established tests such as the fecal occluded blood test (FOBT) and FIT. Approval for a frontline test will require a PMA approval in the US, and the company expects to get feedback from the FDA on their regulatory path forward in H117. The company has three CE marks for different assays in Europe.

The market for CRC screening is large with approximately 225 million people in the US and Europe of screening age, and there is significant pressure to diagnose the disease early. Localized disease has a 90.1% five-year survival rate, which drops to 13.1% following metathesis.1 In the US the current recommendations are that adults aged 50 and older should be tested with one or more of the following to detect CRC:

SEER database

an annual FOBT or FIT;

flexible sigmoidoscopy every five years, with FOBT/FIT every three years; or

colonoscopy every 10 years.

Similarly in Europe there are multiple national initiatives to screen the at-risk population, for instance a FIT test distributed to at-risk individuals once every two years, as in Scotland. The problem with these strategies is that compliance for fecal testing is low (13-60% depending on the study) and, while highly accurate, colonoscopy is invasive and requires sedation. The Cologuard test developed by Exact Sciences has attempted to address some of the performance limitations of other fecal tests, and has significantly improved accuracy. However, the test still underperforms colonoscopy, and adoption was slow in its first full launch year, with only 104k tests sold in 2015.

Exhibit 2: Current 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

649

0.1

Fecal-based test, high cost

Source: FDA, World Gastroenterology Organisation, Exact Sciences, VolitionRx

The limitations of established testing technology have led to the development of an array of blood-based tests (Exhibit 3), which promise to lessen the burden on the patient and improve compliance. The majority of these tests have been promoted by small companies unable to support the large-scale clinical trials necessary for widespread adoption. An exception is Epi proColon (developed by Epigenomics) which was launched in April 2016 in the US after FDA approval for patients that are non-compliant with other testing methodologies. The test received approval from the FDA based on a screening study that compliance with testing increases when patients are given the option of blood-based testing. This result is significant because it provides a pathway for testing methodologies to reach approval that exhibit higher rates of false positives. The FDA initially rejected the Epi proColon application because estimates indicated that only a little over 2% of patients testing positive had CRC (compared to 16% of those with positive FIT), which presented both a burden on the patients on the medical system with the obligatory follow-up colonoscopies. However, the screening study showed that only 0.5% of patients were noncompliant with Epi proColon (compared to 12% for FIT), which would translate into improved overall outcomes.

NuQ has been evaluated in two separate trials for CRC. In a retrospective trial of 4,800 samples from patients presenting with CRC or other bowel diseases, the test showed 81% sensitivity to detecting CRC (at 78% specificity). This trial established the capacity of the test to identify patients with CRC, but had several limitations. Because all the patients included in the screen had a variety of bowel diseases, including polyps and adenomas, one would expect a higher degree of false positives than would be observed in the general population: it is a reasonable assumption that these patients would also have abnormal DNA expression and higher degrees of cell death. However, the test still performed in this background. A limitation is that the retrospective nature of the test limits the capacity to interpret the statistics of the study fairly. To this end, the company performed a prospective trial of 121 patients that were identified in CHU Dinant Godinne – UCL Namur University Hospital in Belgium with symptoms of CRC. In this study a panel of four NuQ assays identified CRC with 91% sensitivity and 90% specificity. These results, if repeatable, would make NuQ the best in class blood-based CRC diagnostic, but additional studies are needed because the number of CRC cases (23) and healthy subjects (20) was low in the sample, due to the large number of patients with other bowel diseases.

Exhibit 3: Blood-based screening tests for CRC

Test Name

Company

CRC sensitivity (%)

False negative rate (%)

Specificity (%)

False positive rate (%)

Cost per test ($)

Method

Availability

Epi proColon

Epigenomics

72.2

27.8

80.8

19.2

141

Septin 9

CE mark in EU, FDA approved

ColonSentry

Gene News

72

28

70

30

350

7 biomarkers

CLIA in US

ColoMarker

EDP Biotech

98

2

84

16

<100

CA11-19

CE mark in EU

Colox

Novigenix

75

25

91

9

29 gene panel

CE mark in EU

EarlyTect Colon Cancer

Genomic Tree

87

13

95.2

4.8

SDC2

Cologic

Phenomenome Discoveries

86

14

90

10

75-95

GTA-446

Canada

CC Detect

Panacea Global

99

1

91

9

200

HAAH

CLIA in US

ColoVantage

Quest (license from Epigenomics)

70

30

89

11

355

Septin 9

CLIA in US

NuQ

VolitionRx

81-91

9-19

78-90

10-22

40-80

Nucleosome

Source: Company reports

One of the distinguishing features of the NuQ CRC test is its ability to detect colorectal adenomas. Adenomas, also referred to as precancerous polyps, are benign growths on the lining of the bowel characterized by a dysregulation of normal cellular function. These growths almost universally precede the development of CRC and are a significant risk factor. A NuQ testing panel was able to identify 75% of adenomas among a population of 430 patients presenting with signs of bowel disease (specificity of 78%). Other blood and fecal-based tests do not detect adenomas with any viable degree of sensitivity (Exhibit 4).

Exhibit 4: Adenoma detection sensitivity

Source: VolitioRx, Epigenomics, Exact Sciences, Applied Proteomics. Note: FOBT = fecal occult blood test, FIT = fecal immunochemical test.

The new triage strategy

The company announced the strategy for the initial commercialization of NuQ for CRC screening in September 2016. It will be launching a test in Europe based on a single normalized CE-marked NuQ assay designed as a follow-up to a positive FIT. The test is not designed to diagnose cancer in the same way as the NuQ panels that have been previously reported, but instead is designed as a companion diagnostic used to rule out some patients that are not at risk to colon cancer. The name for the new test is the NuQ triage colorectal screening test.

The company developed this commercial plan after speaking with European authorities, who expressed the need for a tool to reduce colonoscopies, which are a significant burden on patients and the healthcare system of these countries. In many European jurisdictions (14 of the 28 EU member states), central health authorities have widespread CRC screening programs, where FIT or FOBT tests are distributed to the screening population on a regular basis. Given the high false positive rate of these tests, a large number of these must be followed up with a colonoscopy. The new triage test is meant as an intermediary step of this process where the patient will instead be sent to the doctor for a blood test following a positive FIT result. The company reported that the NuQ test could rule out up to 25% of patients with a positive FIT result that are not at risk for colon cancer, and therefore do not need a follow-up colonoscopy.

The triage test consist of a pair of assays (a diagnostic and a baseline), which is fewer than the panels of four or five tests being explored for the frontline diagnostic. The lower number of assays may translate into better pricing as well as lower the barriers to entry for the product as it will fit more seamlessly into existing blood testing protocols and require less interpretation.

The company will commercialize the triage test by approaching the central health authorities in countries that have established FIT testing protocols. Near-term targets include Belgium, France, Denmark, Scotland and the Republic of Ireland. England is testing a pilot FIT program and may become available as a market soon. The company will employ a small number representatives to pursue market access in these regions and these relationships will likely be leveraged when the frontline NuQ colorectal screening test enters the market.

The addressable market for the triage test is small compared to the frontline lest. There are approximately 136 million patients in Europe eligible for routine CRC screening. However, many fecal testing programs have historically had low compliance rates. A recent study of fecal testing in France found compliance rates between 47% and 54%2 over four consecutive two-year periods (24-27% tested per year). A study in Spain identified a FIT positivity rate of 7.2%,3 similar to rates observed in the US (7.0%).4 This corresponds to a total market of 2.5 million individuals per year across Europe if all nations adopted FIT screening programs, or a little over 1% of the predicted US and European frontline CRC screening market.

  Denis D, et al. (2015) Participation in four rounds of a French colorectal cancer screening programme with guaiac faecal occult blood test: a population-based open cohort study. J. Med. Screen. 22(2), 76-82.

  Quintero E, et al. (2012) Colonoscopy versus Fecal Immunochemical Testing in Colorectal-Cancer Screening. New Eng. J. Med. 366, 697-706.

  Imperiale TF, et al. (2014) Multitarget Stool DNA Testing for Colorectal-Cancer Screening. New Eng. J. Med. 370, 1287-1297.

The company will be releasing more-detailed information about the specifics of the test at the ESMO meeting in October 2016.

Lung cancer

VolitionRx is also developing a NuQ testing panel to identify patients with lung cancer. Lung cancer is another disease that can benefit from early detection, but unlike CRC, widespread screening efforts are limited by technology. The majority of lung cancers are identified after metathesis (57%), when the five-year survival rate is only 4.2%.1 Survival rates are significantly higher (54.8%) if the cancer is detected when still localized.

Despite the significant need for new lung cancer screening methodologies, the market is much smaller than for CRC. Because of its close association with smoking, the population at risk is much lower. The Centers for Medicare and Medicaid Services (CMS) recommends screening for those aged between 55-74 with ≥30 pack per year smoking history and cessation less than 15 years ago, which results in 8.6 million people in the US (compared to 89 million screening population for CRC).

There are a number of different screening methods in general practice (Exhibit 5), but the current standard advocated by the US Preventative Services Task Force (USPSTF) is a yearly low-dose computed tomography (LDCT) scan. LDCT is one of the most effective methods of identifying lung cancer (89% sensitivity, 93% specificity) but is associated with radiation exposure. The amount of radiation exposures is small on an individual basis (2 millisieverts), but in the scale of the total number of screened patients, represents a very large level of exposure with potential health effects. So there is still a medical need for new screening regimens.

The company released interim results of 73 patients (as part of a larger 600 person prospective study) that presented at Centre Hospitalier Universitaire de Liege in Belgium with symptoms of lung disease. The study correctly identified 93% of patients with cancer and successfully discriminated them from chronic obstructive pulmonary disease (COPD) patients (with 91% specificity). These results are comparable to LDCT, albeit on a small data set. The full data is expected to be released in H117.

Exhibit 5: Relative efficacy and cost of lung cancer diagnostics

Test name

Company

Sensitivity (%)

False negative
rate (%)

Specificity (%)

False positive
rate (%)

Cost ($)

Sputum cytology

66

34

99

1

2,500

Needle biopsy

90

10

97

3

9,000

Chest X-ray

54

46

99

1

100

LDCT

89

11

93

7

300

PAULA

Genesys Biolabs

74

26

80

20

95

Lc Detect

Panacea Global

98

2

90

10

200

Percepta

Veracyte

97

3

47

53

4,875

Epi proLung BL Reflex

Epiogenomics

81

19

95

5

NuQ

VolitionRx

93

7

91

9

40-80

Source: Chest Journal5, ASTRO, Cancer Journal, company reports

  Rivera et al., (2013) Chest 143(s5) e142S-e165S.

Pancreatic cancer

Another indication with a desperate need for early screening capabilities is pancreatic cancer. The diagnosis typically is made when symptoms arise as a result of metathesis and a minority of patients (47%) are identified before this point. The five-year survival rate for patients with distant metatheses is also one of the worst in the oncology space at 2.4%, whereas it is 27.1% when localized. Pancreatic cancer survivability could be significantly improved with better diagnostics.

There are substantially fewer established technologies used to test for pancreatic cancer. The primary procedure used to screen patients is endoscopic ultrasound, where an ultrasound device is inserted through the esophagus and a recording is taken through the wall of the stomach. Needless to say, this is a highly invasive procedure that requires anesthesia and carries the risks of complications. The only other screening method in common use is a blood test called CA19-9. Current ASCO guidelines recommend against use of CA19-9 as a screening tool for pancreatic cancer due to its inaccuracy. According to a review of CA19-9 studies, it has 79% sensitivity and 82% specificity.6 Its primary use is to assess the response the therapy for already established pancreatic cancer patients, but is frequently used off label for diagnosis, albeit as part of a larger set of diagnostic procedures.

  Duffy et al., (2009) Tumor markers in pancreatic cancer: a European Group on Tumor Markers (EGTM) status report Annals of Oncology 21, 441-447

These limitations in screening technology and the relatively low incidence of the cancer (53,000 new cases per year in the US)1 is likely the reason why the International Cancer of the Pancreas Screening Consortium does not recommend screening for the general population. Currently, only those individuals with multiple first-degree relatives that have had pancreatic cancer are considered of sufficient risk to warrant screening. We believe that these features severely limit the potential pancreatic screening market, even if VolitionRx can develop and accurate test. Even in the event of substantial clinical success, there is are significant uphill hurdles associated with establishing the market.

The NuQ test for pancreatic cancer has been tested in a two retrospective data sets. The first employed 59 samples from Lund University in Sweden, and detected 92% of cancers with 100% specificity with a NuQ panel of four assays combined with the CA19-9 test. In a follow-up study, the company combined a similar NuQ panel with a carcino-embryonic antigen (CEA), and identified 95% of cancers with 84% specificity in the same 4,800 person sample from Hvidovre Hospital in Denmark used in the CRC test development. The company has initiated a 750-person study at the German Cancer Research Center (DKFZ) with results expected in H117.

Exhibit 6: Pancreatic cancer screening technology comparison

Test Name

Company

Sensitivity (%)

False negative rate (%)

Specificity (%)

False positive rate (%)

Cost per test ($)

EUS

Various

89

11

96

4

500

CA19-9

Various

79

21

82

18

20-40

NuQ + biomarkers

VolitionRx

92-95

3-5

84-100

0-16

40-80

Source: Annals of Oncology,7 VolitionRx, Pancreatology

  Duffy et al., (2010) Tumor markers in pancreatic cancer: a European Group on Tumor Markers (EGTM) status report Annals of Oncology 21, 441-447

Prostate cancer

The company recently released its first results on a NuQ panel for the detection of prostate cancer in April 2016. The test was able to identify 71% of stage-one cancers and 86% of stage-four cancers out of a retrospective sample of 537 men with 93% specificity.

Unlike the other indications that the company is targeting, prostate cancer already has a widely used blood based test: the prostate specific antigen (PSA) test. PSA testing is often combined with digital rectal examination (DRE) to form the standard of detection for the disease. The accuracy of both of these tests varies dramatically in the literature: a meta-analysis in 2003 found sensitivities from 67% to 100% and specificities from 18% to 100% for PSA and from 49% to 69% sensitivity and 18% to 99% specificity for DRE.8

  Mistry K and Cable G, (2003) Meta-analysis of prostate-specific antigen and digital rectal examination as screening tests for prostate carcinoma. J. Am. Board Fam. Med. 16, 95-101

Although the number of men screened each year is relatively large (approximately 20 million per year receive a PSA test),9 the benefits of testing are currently under question. In 2012 the USPSTF recommended against the use of PSA testing for the diagnosis of cancer, not based on the accuracy of the test, but because the benefit to the patient in the event of a diagnosis was small. The number of patients who are impacted by early diagnosis is small because the majority either have prostate cancer advanced enough that detection does not alter the prognosis or are more likely to die from other causes before the benefits of early testing can be realized. Future advances in treatment may affect this assessment, but currently the benefits of testing for prostate cancer are limited.

  Roswell Park Cancer Institute

Exhibit 7: Prostate cancer screening technology comparison

Test Name

Company

Sensitivity (%)

False negative rate (%)

Specificity (%)

False positive rate (%)

Cost per test ($)

DRE

 

53

47

84

16

10-20

PSA

Various

72

28

93

7

50

NuQ

VolitionRx

71-86

14-29

93

7

40-80

Source: J. Am. Board Fam. Med, VolitionRx

Sensitivities

VolitionRx faces a series of both clinical and commercial hurdles before success that are typical of early stage diagnostics companies. The company is engaged in, and has completed, a large number of clinical trials. However, the majority of these studies have been retrospective in nature, using stored samples correlated with medical records. While important for informing the design of testing panels, these preselected populations cannot replicate the complex patient dynamics present in prospective trials, which is why prospective studies are required for marketing authorization. Although the NuQ technology has provided superior sensitivity to existing testing methods in a number of these studies, specificity has rarely exceeded the low 90% range. Specificity in cancer screening has been cited by the FDA and USPSTF as a very significant factor when evaluating a test, because the low incidence rates of these diseases mean false positives can outnumber true positives by orders of magnitude. That being said, we consider the recent analysis advanced by Epigenomics and accepted by the FDA that Epi proColon increases outcomes from a compliance standpoint as a positive regulatory development that could be utilized by VolitionRx as well.

We believe that the company has correctly identified CRC as the lead indication for the platform, because it has a broad, established testing market supported by medical guidelines. However, the other indications that the company is investigating have a series of structural market deficiencies by comparison: lung cancer testing is limited to a set of smokers, the incidence rate for pancreatic cancer is low and the benefit of testing for prostate cancer at all is questionable.

The company has a multi-tiered commercialization strategy for the CRC test, which we believe is a prudent hedging strategy on regulatory risk. The company’s first commercial enterprise, the recently announced CRC triage test strategy that will be pursued in Europe starting in 2017, will be limited in scope. The market is small as it depends on positive FIT tests, pricing demands will be low and the roll-out will be slow because it depends on negotiations with numerous central regulators. We do not expect significant revenue for the company as a whole until approximately 2020 with PMA approval of the CRC test in the US.

As an early-stage company with significant development costs ahead, VolitionRx also has the associated financing risks. We currently forecast the need to seek approximately $60m in additional financing before the company is cash flow positive in 2021.

Valuation

We have increased our valuation to $246m or $10.46 per basic share from $231m or $10.00 per basic share. The increase is predominantly due to rolling forward our NPVs to Q316. We have added the triage CRC test to our model, which we value at $12m based on 33% peak market share of the FIT positive tests in Europe, with a peak sales of $30m. We assume an initial price of $20 per test. This addition is largely offset by delays in our expected commercialization timing for the frontline NuQ CRC test to first sales in late 2017, a net effect of negative $11m. We assign a probability of success for the program as a whole of 30% as we expect significant hurdles to widespread acceptance in line with other diagnostics. We model a blood-based testing market expanding from 11-12% of at risk individuals a year to over 20% by 2033 as market matures with more entrants. We expect an initial price for the frontline test of $40 in the US and $20 in Europe. We will not include the prostate test in our models until it can demonstrate significant superiority to the PSA test in a prospective trial given the limitations we see to entering the entrenched PSA market. We may update our valuation following the release of more information on the triage CRC test at ESMO in October 2016 and following the upcoming clinical data releases expected for CRC, lung, prostate, and endometriosis over the next nine months.

Exhibit 8: VolitionRx valuation

Product

Main Indication

Status

Prob. of commercial success

Launch year

Peak sales ($m)

Patent protection

Economics

rNPV ($m)

NuQ

Colorectal frontline

Development

30%

2017

404

2034

56% peak margin

$170

 

Colorectal triage

Pre-commercialization

30%

2016

30

2034

54% peak margin

$12

 

Lung

Development

30%

2018

145

2034

61% peak margin

$40

Pancreatic

Development

30%

2018

37

2034

58% peak margin

$9

Total

 

 

 

 

 

 

 

$232

Cash and cash equivalents (Q216) ($m)

$14.5

Total firm value ($m)

$246

Total basic shares (m)

23.5

Value per basic share ($)

$10.46

Warrants and options (6/2016, m)

2.2

Weighted average exercise price ($)

$2.35

Cash on exercise ($m)

$5.2

Total firm value ($m)

$251

Non-warrant options (6/2016, m)

2.5

Total number of shares

28.2

Diluted value per share ($)

$8.92

Source: VolitionRx reports, Edison Investment Research

Financials

VolitionRx reported a net loss of $2.9m for Q216. The majority of these costs ($1.7m) were associated with clinical development. We currently project these costs increasing throughout the year (to $9.1m for 2016) as the company advances the CRC program in preparation for 510(k) submission in 2017 and with the advancement of other programs into broader trials. Similarly, we expect an increase in SG&A spending to $6m for the year to support the commercial roll-out of the triage CRC test in Europe and other preparatory activities for commercialization. This marks an increase in the 2016 loss before taxes ($15.1m vs $13.9m previously) and a decrease in 2017 losses ($16.9m vs $18.1m) to account for the new commercialization strategy and commercialization timeline for the frontline test. The company ended Q216 with $14.5m in cash. We currently project that the company will need $60m in additional financing ($25m in 2017, $25m in 2018, and $10m in 2019) before becoming cash flow positive in 2021. This is an increase compared to our previous report on the basis of increased SG&A costs and working capital associated with the triage CRC test and the delay of the frontline CRC test commercialization in Europe to late 2017. We currently record this financing as illustrative debt, but it may result in significant dilution if the company seeks this financing on the equity markets.

Exhibit 9: Financial summary

$'000s

2012

2013

2014

2015

2016e

2017e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

55

0

15

0

0

1,433

Cost of Sales

0

0

0

0

0

(141)

Gross Profit

55

0

15

0

0

1,293

Research & Development

(2,843)

(2,504)

(4,044)

(6,102)

(9,102)

(10,012)

Sales, General & Administrative

(1,295)

(2,072)

(1,908)

(3,904)

(6,051)

(8,171)

EBITDA

 

 

(4,083)

(4,576)

(5,937)

(10,006)

(15,127)

(16,890)

Operating Profit (before GW and except.)

(4,083)

(4,576)

(5,937)

(10,006)

(15,127)

(16,890)

Intangible Amortisation

0

0

0

0

0

0

Other

0

0

0

0

26

0

Exceptionals

0

0

0

0

0

0

Operating Profit

(4,083)

(4,576)

(5,937)

(10,006)

(15,127)

(16,890)

Net Interest

0

0

0

0

0

29

Other

(39)

840

(2,320)

471

(49)

0

Profit Before Tax (norm)

 

 

(4,083)

(4,576)

(8,358)

(9,666)

(15,127)

(16,861)

Profit Before Tax (FRS 3)

 

 

(4,122)

(3,736)

(8,258)

(9,535)

(15,176)

(16,861)

Tax

0

0

(0)

5

0

0

Deferred tax

0

0

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(4,083)

(4,576)

(8,358)

(9,661)

(15,127)

(16,861)

Profit After Tax (FRS 3)

(4,122)

(3,736)

(8,258)

(9,530)

(15,176)

(16,861)

Average Number of Shares Outstanding (m)

9.4

10.8

13.5

17.7

22.6

23.5

EPS - normalised ($)

 

 

(0.44)

(0.42)

(0.62)

(0.54)

(0.67)

(0.72)

EPS - FRS 3 ($)

 

 

(0.44)

(0.34)

(0.61)

(0.54)

(0.67)

(0.72)

Dividend per share ($)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,522

1,065

1,097

1,489

1,355

1,221

Intangible Assets

1,430

1,002

809

705

672

672

Tangible Assets

91

63

289

784

683

549

Other

0

0

(0)

(0)

(0)

(0)

Current Assets

 

 

416

941

2,192

6,070

5,912

16,085

Stocks

0

0

0

0

0

7

Debtors

0

0

0

0

0

255

Cash

376

889

2,139

5,916

5,758

15,669

Other

39

53

53

154

154

154

Current Liabilities

 

 

(695)

(957)

(2,713)

(1,120)

(1,458)

(1,674)

Creditors

(695)

(957)

(2,713)

(1,120)

(1,458)

(1,674)

Short term borrowings

0

0

0

0

0

0

Long Term Liabilities

 

 

(635)

(433)

(352)

(548)

(477)

(25,477)

Long term borrowings

0

0

0

0

0

(25,000)

Other long term liabilities

(635)

(433)

(352)

(548)

(477)

(477)

Net Assets

 

 

607

617

224

5,891

5,332

(9,845)

CASH FLOW

Operating Cash Flow

 

 

(2,315)

(3,084)

(4,141)

(8,766)

(13,339)

(15,251)

Net Interest

0

0

0

0

0

0

Tax

0

0

0

0

0

0

Capex

(91)

(1)

(303)

(352)

(30)

(30)

Acquisitions/disposals

0

0

0

0

0

0

Financing

2,576

2,828

5,627

12,498

13,314

0

Dividends

0

0

0

0

0

0

Other

0

0

0

0

(41)

0

Net Cash Flow

171

(257)

1,183

3,379

(97)

(15,281)

Opening net debt/(cash)

 

 

(348)

(376)

(889)

(2,139)

(5,916)

(5,758)

HP finance leases initiated

0

0

0

0

0

0

Exchange rate movements

(40)

4

(44)

13

51

0

Other

-103

765

111

385

-112

191

Closing net debt/(cash)

 

 

(376)

(889)

(2,139)

(5,916)

(5,758)

9,332

Source: VolitionRx reports, Edison Investment Research

Contact details

Revenue by geography

VolitionRx
1 Scotts Road
#25-05 Shaw Centre
Singapore 228208
www.volitionrx.com

N/A

Contact details

VolitionRx
1 Scotts Road
#25-05 Shaw Centre
Singapore 228208
www.volitionrx.com

Revenue by geography

N/A

Management team

Chief executive officer: Cameron Reynolds MBA

Chief financial officer: David Kratochvil

Mr Reynolds founded the company in Singapore in 2010. From 2004 until 2011, Mr Reynolds founded and served as managing director and director of Mining House, where he was responsible for identifying potential mining projects. From 2005 until present, Mr Reynolds has held several board directorships. Cameron was educated at the University of Western Australia (Bachelor of Commerce and MBA).

Mr. Kratochvil has more than 28 years of broad financial sector experience and leadership. He served as Managing Director of Euro Pacific Capital in the Corporate Finance department, overseeing the firm's investment banking efforts across a variety of sectors. At Euro Pacific since 2008, Mr. Kratochvil also served as Director of Research where he managed a team of equity analysts and increased research coverage. Mr. Kratochvil earned a Master of Business Administration (MBA) in Finance and International Business from the University of Chicago's Booth School of Business.

Chief scientific officer: Jake Micallef PhD MBA

Chief medical officer: Jason Terrell, MD

Dr Jake Micallef is an experienced scientific executive with expertise in research and development, and in managing early-stage biotechnical companies. He joined Cronos Therapeutics in 2004. In 2006 Cronos was listed in the UK on AIM, becoming ValiRx. Dr Micallef continued to work as technical officer for ValiRx, where he in-licensed the HyperGenomics and Nucleosomics technologies and co-founded ValiBio, which is now Belgian Volition, a subsidiary of Singapore Volition. Dr Micallef was educated at King’s College London (BSc, Biology and Chemistry; PhD Physical Chemistry); St Thomas’s Hospital Medical School, London (MSc Chemical Pathology); and Imperial College Management School (MBA).

Dr Terrell has a strong grounding in both medicine and more specifically in diagnostics. He currently owns and operates multiple diagnostic laboratories in Texas. Since 2011, he has been medical director of CDEX, a US-listed company developing drug validation technology, serving on the board since 2013. Dr Terrell was educated at Hardin-Simmons University (Biochemistry), where he graduated summa cum laude, receiving the Holland Medal of Honor as the top graduate in the School of Science and Mathematics. He then attended the University of Texas at Houston Medical School and affiliate MD Anderson Cancer Center (Doctor of Medicine).

Management team

Chief executive officer: Cameron Reynolds MBA

Mr Reynolds founded the company in Singapore in 2010. From 2004 until 2011, Mr Reynolds founded and served as managing director and director of Mining House, where he was responsible for identifying potential mining projects. From 2005 until present, Mr Reynolds has held several board directorships. Cameron was educated at the University of Western Australia (Bachelor of Commerce and MBA).

Chief financial officer: David Kratochvil

Mr. Kratochvil has more than 28 years of broad financial sector experience and leadership. He served as Managing Director of Euro Pacific Capital in the Corporate Finance department, overseeing the firm's investment banking efforts across a variety of sectors. At Euro Pacific since 2008, Mr. Kratochvil also served as Director of Research where he managed a team of equity analysts and increased research coverage. Mr. Kratochvil earned a Master of Business Administration (MBA) in Finance and International Business from the University of Chicago's Booth School of Business.

Chief scientific officer: Jake Micallef PhD MBA

Dr Jake Micallef is an experienced scientific executive with expertise in research and development, and in managing early-stage biotechnical companies. He joined Cronos Therapeutics in 2004. In 2006 Cronos was listed in the UK on AIM, becoming ValiRx. Dr Micallef continued to work as technical officer for ValiRx, where he in-licensed the HyperGenomics and Nucleosomics technologies and co-founded ValiBio, which is now Belgian Volition, a subsidiary of Singapore Volition. Dr Micallef was educated at King’s College London (BSc, Biology and Chemistry; PhD Physical Chemistry); St Thomas’s Hospital Medical School, London (MSc Chemical Pathology); and Imperial College Management School (MBA).

Chief medical officer: Jason Terrell, MD

Dr Terrell has a strong grounding in both medicine and more specifically in diagnostics. He currently owns and operates multiple diagnostic laboratories in Texas. Since 2011, he has been medical director of CDEX, a US-listed company developing drug validation technology, serving on the board since 2013. Dr Terrell was educated at Hardin-Simmons University (Biochemistry), where he graduated summa cum laude, receiving the Holland Medal of Honor as the top graduate in the School of Science and Mathematics. He then attended the University of Texas at Houston Medical School and affiliate MD Anderson Cancer Center (Doctor of Medicine).

Principal shareholders

(%)

Lagoda Investment Management

6.9%

Dr Martin Faulkes

5.5%

Guy Innes

5.2%

Cameron Reynolds

4.7%

Southpoint Capital Advisors

3.4%

Knoll Capital Management

2.0%

Southpoint Capital

4.5%

Companies named in this report

Exact Sciences (EXAS); Epigenomics (EPGNY); Panacea Global (PANG)

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 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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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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 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 2016. “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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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