Viralytics — Looking towards pivotal Cavatak combo studies

Viralytics — Looking towards pivotal Cavatak combo studies

Viralytics continues to report impressive preliminary data for Cavatak in combination with immune checkpoint inhibitors (ICIs), whether administered intravenously (iv) or by intra-tumoural injection. Viralytics is currently recruiting additional patients in expansion cohorts in melanoma, lung and bladder cancers in order to obtain more robust estimates of tumour response rates. It has announced plans to initiate four Phase I studies in additional indications and has commenced planning for a potential pivotal study of Cavatak plus Yervoy in melanoma patients who had failed prior single-agent, anti-PD1 ICI therapy, a serious unmet medical need. Updates on MITCI, CAPRA and Keynote 200 are expected in Q218. We increase our valuation to A$469m or A$1.95/share (vs A$408m and A$1.70/share).

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Viralytics

Looking towards pivotal Cavatak combo studies

FY17 results

Pharma & biotech

5 December 2017

Price

A$0.72

Market cap

A$173m

US$0.76/A$

Net cash (A$m) at 30 September 2017

27.7

Shares in issue

240.3m

Free float

85%

Code

VLA

Primary exchange

ASX

Secondary exchange

OTCQX

Share price performance

%

1m

3m

12m

Abs

(8.9)

(20.6)

(37.8)

Rel (local)

(9.5)

(24.6)

(43.6)

52-week high/low

A$1.3

A$0.6

Business description

Viralytics is a biopharmaceutical company developing Cavatak oncolytic virotherapy to target late-stage melanoma and other solid tumour types. It is trialling Cavatak as a monotherapy and in combination with checkpoint inhibitors. The virus can be delivered intravenously or by intralesional injection.

Next events

Initiate uveal melanoma Phase I

Q4 CY17

Initiate head and neck cancer Phase I

Q1 CY18

MITCI, CAPRA, Keynote 200 updates

Q2 CY18

Analysts

Dennis Hulme

+61 (0)2 9258 1161

Juan Pedro Serrate

+44 (0)20 3681 2534

Viralytics is a research client of Edison Investment Research Limited

Viralytics continues to report impressive preliminary data for Cavatak in combination with immune checkpoint inhibitors (ICIs), whether administered intravenously (iv) or by intra-tumoural injection. Viralytics is currently recruiting additional patients in expansion cohorts in melanoma, lung and bladder cancers in order to obtain more robust estimates of tumour response rates. It has announced plans to initiate four Phase I studies in additional indications and has commenced planning for a potential pivotal study of Cavatak plus Yervoy in melanoma patients who had failed prior single-agent, anti-PD1 ICI therapy, a serious unmet medical need. Updates on MITCI, CAPRA and Keynote 200 are expected in Q218. We increase our valuation to A$469m or A$1.95/share (vs A$408m and A$1.70/share).

Year
end

Revenue
(A$m)

PBT*
(A$m)

EPS*
(c)

DPS*
(c)

P/E
(x)

Yield
(%)

06/16

4.7

(8.0)

(3.8)

0.0

N/A

N/A

06/17

6.5

(11.3)

(4.7)

0.0

N/A

N/A

06/18e

5.9

(12.0)

(5.0)

0.0

N/A

N/A

06/19e

6.1

(12.5)

(5.2)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding exceptionals and share-based payments.

Cavatak/Yervoy responses where ICI therapy failed

Updated preliminary data presented at SITC in November for melanoma patients treated with Cavatak oncolytic virus in combination with Yervoy in the MITCI study included response rates of 29% in patients who had failed prior single-agent PD1 therapy, which compares to response rates of 11-14% reported for Yervoy alone. The Cavatak/Yervoy combo was very well tolerated. Planning has commenced for a pivotal study in this indication which could start in Q418, if the expanded MITCI study continues to deliver positive data.

iv Cavatak promising, further indication expansion

Preliminary tumour response rates from the Keynote-200 study of intravenous Cavatak plus Keytruda in lung and bladder cancer (30% and 28% respectively) were higher than reported for Keytruda monotherapy, which supports the efficacy of Cavatak when administered iv. The four new Phase I studies planned for FY18 (uveal melanoma, head and neck cancer, metastatic colorectal cancer and iv administration in melanoma) will generate considerable information about the potential breadth of application of Cavatak, which is also likely to be of considerable interest to potential partners.

Valuation: Increased to A$469m or A$1.95/share

Our valuation increases to A$469m or A$1.95/share (vs A$408m or A$1.70/share) as we add new indications for head and neck and colorectal cancer (replacing prostate), roll forward the DCF model and defer forecast deal timing to FY19. Viralytics had A$27.7m cash at 30 September 2017, sufficient to complete the ongoing Cavatak combination clinical trials (MITCI, CAPRA and STORM/Keynote 200), and the four planned Phase I studies. A pivotal trial of Cavatak plus Yervoy in melanoma would likely require additional funding (we model partner funding).

Investment summary

Company description: Improving cancer immunotherapy

Viralytics is developing the oncolytic virus, Cavatak, for use in immunotherapy treatments for a range of cancers. Cavatak is a proprietary formulation of a common cold virus, Coxsackievirus A21 (CVA21), in clinical development for late-stage melanoma, lung and bladder cancer, with potential applications in a range of other cancers. When injected into melanoma lesions, Cavatak achieved a 28% response rate as a single agent, and preliminary response rates of 60% and 57% when combined with ICI drugs Keytruda and Yervoy, respectively. Adverse events rates have been low in all Cavatak trials so far, even when combined with therapies usually associated with high adverse event rates. Initial results from the Keynote 200 Phase I/II study (in collaboration with Merck) produced encouraging signs that Cavatak will also be effective when administered intravenously (iv); iv Cavatak is being trialled in combination with Merck’s Keytruda in lung and bladder cancer.

Valuation: rNPV of A$469m, or A$1.95 per share (undiluted)

We value Viralytics at A$469m, or A$1.95 per share (undiluted), using a risk-adjusted net present value method to discount future cash flows through to 2044 in metastatic melanoma, bladder cancer, non-small cell lung cancer, head and neck cancer and metastatic colorectal cancer (mCRC). We apply a 40% probability of success to intralesional injection of Cavatak in melanoma to reflect positive clinical data and the clear market opportunity for Cavatak plus Yervoy in patients who have failed PD1/L1 ICI therapy, a 10% probability in mCRC and 15% probability in other indications. Our approach assumes a partnering deal or out-licensing of Cavatak in FY19, with costs of subsequent clinical development borne by the partner/licensee.

Sensitivities: Keynote 200 and combo trial outcomes are key

Viralytics is subject to typical biotech company development risks, including the unpredictable outcome of trials, regulatory decisions, success of competitors, financing and commercial risks. In particular, it has a very high single-product risk, with the entirety of its value residing in Cavatak. The investment case hinges on the outcome of clinical trials and, assuming data are positive, the company’s ability to secure a partnership (or further capital) to advance Cavatak into late-stage trials. Ideally, a partner would have an established oncology franchise with the resources and experience to evaluate Cavatak in multiple cancer indications. The rapidly evolving treatment landscape for melanoma means that the greatest commercial opportunity for Cavatak is likely to be in combination with checkpoint inhibitors or other targeted agents. Initial results from Keynote 200 suggest that combining iv Cavatak with Keytruda leads to high response rates in lung and bladder cancer tumours following iv administration, but only a small number of patients have been evaluated so far. Further results from the Keynote 200 will be important pointers to utility beyond melanoma, although Cavatak can also be administered by ultrasound or CT-guided intralesional injections, as in the upcoming study in mCRC liver metastases.

Financials: Sufficient cash to initiate a pivotal trial

Viralytics reported cash of A$27.7m at 30 September 2017. The company has the resources to complete ongoing Cavatak combination clinical trials (MITCI, CAPRA and STORM/Keynote 200), plus additional Cavatak combination trials being planned. If a partner is not secured for Cavatak, Viralytics has sufficient resources to initiate a pivotal trial of Cavatak plus Yervoy in melanoma patients who are refractory to ICI therapy, but would need additional funds to complete the trial. Given the positive signs of efficacy to date, prospects for attracting a big pharma partner appear promising.

Building evidence of efficacy for a Cavatak deal

Viralytics is actively pursuing a clinical trial programme to confirm the potential of Cavatak as an anticancer therapy. The emphasis of the programme is on combination immunotherapy and demonstrating that Cavatak is efficacious when administered intravenously. Exhibit 1 summarises the ongoing and completed Cavatak clinical trials.

Exhibit 1: Overview of ongoing and completed Cavatak clinical trials

Route

Indication

Stage

Development notes

Intralesional

Melanoma

Phase Ib

MITCI Phase Ib study in combination with Yervoy. Interim results include: ORR 29% (2/7) in patients who had failed prior single line anti-PD1/L1 ICI therapy; ORR 57% (8/14) in ICI-naive patients). Expansion cohort of ~44 patients who failed prior therapy with PD1/L1 ICI commenced recruitment Q117 (total n=60).

Intralesional

Melanoma

Phase Ib

CAPRA Phase Ib study in combination with Keytruda (interim results ORR 60% (9/15)). In April 2017 the trial was expanded to enrol up to 50 patients vs the original target of 30 patients. None of the subjects has undergone prior PD1/L1 ICI therapy.

Intravenous

Melanoma, bladder, lung, prostate

Phase I

Phase I STORM Part A trial (n=18; ORR in high dose cohort 10% (1/10, 1 PR in prostate cancer). Tumour biopsies suggest that Cavatak replicates in melanoma, lung and bladder tumours after iv administration.

Intravenous

Bladder, lung

Phase Ib

Phase Ib Keynote 200 (STORM Part B) trial of iv Cavatak plus Keytruda. Phase I dose escalation complete. Expansion cohorts are recruiting ~40 bladder and ~40 lung cancer patients. Preliminary efficacy included ORR on intention to treat basis of 3/10 (30%) and 5/18 (28%) for lung and bladder cancer, respectively.

Intralesional

Melanoma

Phase IIa

Phase II CALM study in melanoma (n=57, ORR 28%, durable response in 21% of patients). Monotherapy. Study complete.

Intralesional

Melanoma

Phase IIa

Phase II CALM immune-profiling extension study in malignant melanoma (n=13). Collected tumour biopsies and other immune response measures. ORR 30%. Study complete.

Intravesicular

Non-invasive bladder cancer

Phase I

Phase I CANON study. Intravesicular administration Cavatak as a single agent and with mitomycin C (n=16, 1 CR). Biopsies showed Cavatak increases immune cell infiltrates and PD-L1 expression vs untreated controls.

Source: Edison Investment Research. Note: ORR = overall response rate, PR = partial response, CR = complete response.

MITCI: Impressive Yervoy combo response rates

Viralytics presented an update at the Society for Immunotherapy of Cancer (SITC) meeting held in Washington DC on 7-11 November 2017 which showed that the MITCI study continues to deliver impressive response rates in patients with PD1-refractory melanoma. MITCI is a Phase Ib trial of intralesional Cavatak in combination with the anti-CTLA-4 ICI Yervoy in patients with advanced melanoma, many of whom had undergone prior ICI immunotherapy.

The preliminary best overall tumour response rate (BORR) in patients who have not undergone prior anti-PD1 therapy (PD1 naïve) was 57% (8/14, see Exhibits 2 and 4), while the response rate in patients who had failed prior single-line anti-PD1 therapy was 29% (2/7, Exhibits 3 and 5).

Exhibit 2: Best overall response for patients naïve to ICI therapy

Exhibit 3: Best overall response for patients with prior single-line anti-PD1 therapy

Source: Viralytics corporate presentation November 2017

Exhibit 4: MITCI ICI therapy naïve responses

Exhibit 5: MITCI prior single-line anti-PD1 therapy

Source: Viralytics corporate presentation November 2017. Note: these so-called spider plots show the change in target lesions for each patient relative to baseline at each response assessment.

Cavatak outperforms other Yervoy combos

The preliminary response rates in patients who have failed prior PD1 therapy in the MITCI trial are very encouraging. Exhibit 6 compares response rates in the different patient subgroups in the MITCI trial to response rates reported for comparable populations of melanoma patients treated with Yervoy as a single agent or in combination with other oncolytic virus immunotherapies, with the oral IDO1 inhibitor epacadostat, or with the anti-PD1 ICI dug Opdivo.

The 29% response rate among patients who had failed prior anti-PD1 treatment but had not been previously treated with Yervoy compares favourably to a response rate of only 14% (14/97) when patients who had failed treatment with the PD-1 drug Keytruda were treated with Yervoy on its own, and 11% in Yervoy pivotal studies. Given that anti-PD1 drugs are becoming widely used in first line treatment of advanced melanoma, this class of patients represents a substantial potential market opportunity for Cavatak.

We also note that the 57% response rate in the MITCI trial in PD1 naïve patients is higher than that seen when other drugs were combined with Yervoy in PD1-naïve patients. This includes the 39% (39/98) response rate from a randomised Phase II trial of Yervoy combined with Amgen’s approved oncolytic virotherapy, Imlygic (T-Vec) in which 98% of subjects were PD1 naïve (Chesney et al, ASCO 2017). We note that Amgen is focusing on combining Imlygic with PD1 inhibitors rather than Yervoy in its late-stage development programme.

Although the response rates for Cavatak plus Yervoy are higher than those reported for historical studies, the MITCI data so far includes response data on only 25 patients; the results will need to be further confirmed in the expanded study which will recruit 60 patients in total, with a focus on recruiting additional subjects who have failed prior anti-PD1 therapy.

While bearing in mind that the number of patients who have been assessed to date is small, and that response rates may change as additional patients are assessed, at this early stage it appears that Cavatak is more effective at inducing immune responses in melanoma patients in combination with Yervoy than any other therapy except PD1 inhibitors such as Opdivo, and the Yervoy/Opdivo combination is poorly tolerated by patients.

Exhibit 6: Tumour response rates for Cavatak/Yervoy vs other Yervoy combos in melanoma

Cavatak/Yervoy

Imlygic/Yervoy

HF10/Yervoy

Epacadostat (IDO1)/
Yervoy

Yervoy

Opdivo/ Yervoy

Patient subgroup

count

%

count

%

count

%

count

%

%

%

Failed PD1* only

(2/7)

29%

 

 

 

 

 

 

14%

PD1/L1 naïve

(8/14)

57%

(38/98)**

39%

(18/42)

43%

(9/30)

30%

10-19%#

58%

Grade 3/4 treatment related adverse events


(4/38)


11%


28%


37%


23%


20-27%


55%

Source: Edison Investment Research; Viralytics; Chesney et al ASCO 2017 abstract 9509 (Imlygic); Andtbacka et al ASCO 2017 abstract 9510 (HF10); Gibney et al Eur J Cancer.2015; 51: S106-7 (Epacadostat); Long et al SMR abstract 2016, Zimmer et al 2017, Bowyer et al 2016 (Yervoy alone); Larkin et al 2015 (Opdivo/Yervoy). Notes: *Includes anti-PD1 and anti PD-L1 therapies; **2/98 patients had prior PD1 therapy - separate breakdown not provided; #19% response rate as a first line treatment (Larkin et al 2015).

Low adverse event rate is a plus for Cavatak/Yervoy combo

No Cavatak-related grade 3 or higher adverse events have been reported in the MITCI study, and only four of the 38 patients (11%) who have commenced treatment have experienced Yervoy-related grade 3 or 4 adverse events (six grade 3/4 adverse events in these four patients - fatigue, elevated liver enzymes, pruritus, dehydration, hyperglycaemia).

The 11% treatment-related adverse event (TRAE) rate in the MITCI study is much lower than the 20-27% grade 3 TRAE rate reported for Yervoy on its own in advanced melanoma, and the 55% TRAE rate when Yervoy was combined with Opdivo. The results reported to date suggest that a Cavatak/Yervoy combination is much better tolerated than Opdivo/Yervoy, with similar efficacy. In this regard it is notable that there have been no cases of severe diarrhoea, colitis or pneumonitis, which are a common occurrence with other Yervoy treatment regimens. If the low adverse event rate for the Cavatak/Yervoy combo is confirmed in larger studies, it could give the combo a competitive advantage (if approved).

Potential for a pivotal study or even accelerated approval application if circumstances are right

Viralytics has commenced planning for a pivotal study of intralesional Cavatak plus Yervoy in melanoma patients who have failed treatment with a single PD1/L1 therapy. The trial could commence in Q418 if the combination therapy continues to display durable anti-tumour activity in the MITCI expansion cohort. Based on advice to date the company believes that a study in 200-220 patients randomised to Cavatak plus Yervoy vs Yervoy monotherapy would be appropriately sized. We estimate that cost of such a study would be in the order of US$20m, so it would be within the capacity of Viralytics to conduct this study on its own if it raised additional funding.

However, we believe that under certain circumstances there is the potential that the MITCI data could be used to support an application for accelerated approval in the US. This would depend on continued high response rates in the additional 44 patients (preferably together with continued low adverse event rates) as well as there continuing to be a significant unmet need for an effective treatment for this patient group (in this regard Amgen’s Phase III Imlygic/Yervoy combo trial (NCT01740297) will be an important one to watch).

We note that the FDA approved Bavencio (avelumab) for metastatic Merkel cell carcinoma in March 2017 based on a 33% response rate in an 88-patient, single-arm trial. This data set is not much larger than the one Viralytics will have at the completion of the enlarged MITCI study.

At this stage, it is difficult to tell how realistic a prospect an application for accelerated approval would be; in our forecasts we continue to assume that a Phase III study will be required before Cavatak receives market approval.

CAPRA: Cavatak plus Keytruda is a potential first-line combo

Viralytics is testing the combination of intralesional Cavatak with Keytruda (pembrolizumab) in advanced melanoma (Stage IIIB/C and IV) in the Phase Ib CAPRA study. Phase Ib data from the first 23 assessable patients which was presented at SITC in November showed an objective response rate of 61% (4/23), including responses in seven of 11 patients with the most advanced Stage IV M1c disease (Exhibit 9). Importantly, only three of 26 (12%) enrolled patients experienced grade 3/4 TRAEs were observed, all of which were Keytruda related. The trial had enrolled 26 of the target of 50 patients as of early November.

Exhibit 7: Spider plots of tumour responses from CAPRA, by disease stage

Source: Viralytics corporate presentation November 2017

Exhibit 7: Spider plots of tumour responses from CAPRA, by disease stage

Source: Viralytics corporate presentation November 2017

The 61% preliminary response rate for Cavatak plus Keytruda in the CAPRA study is higher than the published rates for either agent used alone in late-stage melanoma: Cavatak 28% and Keytruda circa 33%. Exhibit 10 also shows that the CAPRA response rate is comparable to the 58% response rate in PD1-naïve patients for the approved Opdivo/Yervoy combination, and 57% and 58% for Keytruda combined with Imlygic and epacadostat, respectively, in preliminary studies. Exhibit 10 highlights that the tolerability of Cavatak plus Keytruda was much better than for the other combinations. In particular, Grade 3/4 TRAEs were reported for 55% of patients in the Phase III trial of the approved Opdivo/Yervoy combination, whereas they have only been reported for 12% of patients so far in the CAPRA study, none of which were Cavatak-related.

Epacadostat and Imlygic are both in Phase III studies in combination with Keytruda, with data expected in 2018.

Exhibit 8: Response and adverse event rates for select ICI combos in PD1 naïve melanoma

Cavatak/

Keytruda

Imlygic/

Keytruda

Epacadostat/

Keytruda

Yervoy/

Opdivo

PD1/L1 naïve response rate

61%

57%

58%

58%

Grade 3/4 treatment related adverse events

8%

33%

19%

55%

Source: Edison Investment Research

Keynote 200 - encouraging initial lung and bladder responses

Viralytics also presented initial data at SITC from the expansion cohorts of the Keynote 200 trial, which is being conducted in collaboration with Merck. The expansion cohorts of Keynote 200 are exploring whether viral replication in tumours following intravenous (iv) Cavatak administration can boost the efficacy of Keytruda in lung and bladder cancer patients.

Data was presented on the preliminary assessment of 28 checkpoint naïve patients. Nine of the 28 patients were not evaluable for target lesion response assessment due to early disease progression or study discontinuation. The early disease progression in part reflects the fact that this “all-comers” study is being conducted in a heavily pre-treated patient population, with 28% and 58% of the advanced bladder cancer and NSCLC patients, respectively, having received two or more prior therapies.

Exhibit 11 show that among the 19 evaluable patients responses were observed in three of six (50%) advanced small cell lung cancer (NSCLC) patients and five of 13 (38%) bladder cancer patients. On an intention to treat (ITT) basis, which includes the nine early withdrawals, the response rates were 3/10 (30%) and 5/18 (28%) for lung and bladder cancer, respectively.

Exhibit 9: Preliminary tumour responses in Keynote 200 assessable patients

Exhibit 10: Cavatak combo therapy boosts PD-L1 expression

Source: Viralytics investor presentation November 2017. Notes: ** patient currently on study; ++ day 176 response assessment; +++ day 43 response assessment. Response assessments based on irRECIST – dotted lines represent cut-offs for partial response or tumour progression.

Source: Viralytics. Note: IHC scoring 0=negative, 1=weak positive, 2=positive, 3=strong positive.

Exhibit 9: Preliminary tumour responses in Keynote 200 assessable patients

Source: Viralytics investor presentation November 2017. Notes: ** patient currently on study; ++ day 176 response assessment; +++ day 43 response assessment. Response assessments based on irRECIST – dotted lines represent cut-offs for partial response or tumour progression.

Exhibit 10: Cavatak combo therapy boosts PD-L1 expression

Source: Viralytics. Note: IHC scoring 0=negative, 1=weak positive, 2=positive, 3=strong positive.

While bearing in mind the limitations of cross-trial comparisons and the fact that only a small number of patients have been evaluated to date, the preliminary ITT response rates for iv Cavatak plus Keytruda compare favourably to response rates to Keytruda monotherapy in second line (pre-treated) NSCLC (17-18%) and bladder cancer (21%) in pivotal studies, as shown in Exhibit 13.

Exhibit 11: Preliminary Keynote 200 response rates vs response rates in pre-treated patients in Keytruda pivotal studies

NSLC

Bladder

count

%

count

%

Cavatak/ Keytruda evaluable patients

3/6

50%

5/13

38%

Cavatak/ Keytruda ITT

3/10

30%

5/18

28%

Keytruda monotherapy pivotal studies

17-18%

21%

Source: Viralytics, Keytruda prescribing information Table 19 (Keynote-010) and Table 22 (Keynote-045).

Exhibit 12 above shows that 15 days after the start of Cavatak therapy, there was a significant increase in the PD-L1 expression in tumours that were negative or only weakly positive for PD-L1 at the start of the study. The increased PD-L1 expression is a positive outcome because patients with high PD-L1 expression typically respond better to anti-PD1/L1 therapy. For example, in the Keynote-010 study of Keytruda in pre-treated NSLC patients, the response rate in patients with high PD-L1 tumour expression was ~30% vs ~10% for patients with low PD-L1 tumour expression.

So far 64 out of the target of 90 patients have been enrolled in Keynote 200 part B. A further clinical update on the study is expected in Q218.

Looking to target additional cancers and immunotherapy combinations

Viralytics has encountered strong interest in assessing Cavatak in combination with ICI drugs in additional settings and has announced plans to initiate 4 new Phase I trials by June 2018, as shown in Exhibit 14. We expect these studies to generate additional information about the potential breadth of applicability of Cavatak at a relatively low cost – likely around A$1-2m per study. We expect that this information to be of particular interest to potential partners who may be assessing how Cavatak would fit into their own product development pipeline.

Exhibit 12: Proposed timetable of studies in additional indications over coming year

Study

Planned start (CY)

CLEVER study of iv Cavatak plus Yervoy in uveal melanoma with liver metastases

Q417

ITCAHN study of intralesional Cavatak plus Keytruda in head and neck cancer

Q118

PaCKMAN study of iv Cavatak plus Keytruda in advanced melanoma.

Q118

Intralesional Cavatak plus an un-named checkpoint inhibitor in colorectal cancer metastatic to the liver

Q218

Study

CLEVER study of iv Cavatak plus Yervoy in uveal melanoma with liver metastases

ITCAHN study of intralesional Cavatak plus Keytruda in head and neck cancer

PaCKMAN study of iv Cavatak plus Keytruda in advanced melanoma.

Intralesional Cavatak plus an un-named checkpoint inhibitor in colorectal cancer metastatic to the liver

Planned start (CY)

Q417

Q118

Q118

Q218

Source: Edison Investment Research, Viralytics

Our comments on the rationale for each of the studies include:

iv Cavatak plus Yervoy in uveal melanoma liver metastases

Liver metastases in uveal melanoma represent a serious unmet medical need for which there are no effective drug treatments. Uveal melanoma is rare form of melanoma occurring in the eye, representing ~5% of melanoma cases 1. Following local resection of the primary tumour of the eye about half of people will suffer a recurrence, with 90% having liver metastases. Uveal melanomas behave differently to melanomas arising in the skin, and no prospective randomised trial has ever demonstrated an improvement in overall survival for metastatic uveal menanoma1. Response rates to single agent anti-PD1 therapy are only 3-4% in uveal melanoma2. If Cavatak plus the combo therapy can demonstrate efficacy in metastatic uveal melanoma it will be the only treatment to have done so.

  Skin Cancer Foundation (US).

  Melanoma Institute Australia

Intralesional Cavatak plus Keytruda in head and neck cancer

This study will investigate whether intralesional Cavatak can increase the response rate to Keytruda, in a similar fashion to the improvements see in the CAPRA study in melanoma. Viralytics has previously treated four HNSCC patients with Cavatak in a Phase I study that ended in 2012. Keytruda is approved as a second line treatment for squamous cell carcinoma of the head and neck (HNSCC), based on a 16% ORR in a study of 174 patients with previously-treated disease.

We note that Amgen’s Imlygic plus Keytruda combo is currently being investigated in the 40-patient Phase Ib component of a Phase Ib/III study in HNSCC3.

  Harrington et al; Annals of Oncology, Volume 28, Issue suppl_5, 1 September 2017

iv Cavatak in melanoma

The majority of metastatic melanoma patients do not a have a readily accessible lesion for injection because the primary tumour in the skin has previously been excised. iv Cavatak could be a convenient way of treating these patients, and could potentially ensure that Cavatak is accessible for all metastatic melanoma patients.

Intralesional Cavatak plus un-named checkpoint inhibit in colorectal cancer liver metastases

Viralytics plans to test intralesional Cavatak plus an un-named checkpoint inhibit in patients with microsatellite-stable colorectal cancer (CRC) who have developed liver metastases.

Keytruda and Yervoy are approved for treating a small subset of metastatic colorectal cancer (mCRC) patients, with treatment limited to the 4-5% of mCRC4 that have tumours with a high mutation burden identified as microsatellite instability high (MSI-H) and mismatch repair deficient (dMMR). PD1 ICI have not been shown to be effective in the other 95% of mCRC patients who have microsatellite-stable disease. In studies of PD-1 checkpoint inhibitors in mCRC patients there was only one responder among 33 patients, and that patient was MSI-H5.

  Decision Resources Group, ESMO biomarker factsheet.

  Le DT, et al. New England Journal of Medicine. 2015; 372:2509-2520

CRC is the third most common cancer in the US with 135,000 new cases and 50,260 deaths expected in the US in 2017; globally there were estimated to be 1.4m new cases and 700k deaths in 2012. About 20% of CRC patients eventually develop liver metastases6, for which there are few effective treatments other than surgery. While this appears to be a higher-risk study, we expect that even a single responder would attract considerable commercial interest.

  Manfredi et al Ann Surg. 2006 Aug; 244(2): 254–259.

Separately, we note that there is continued interest by big pharma in investigating checkpoint inhibitor combinations in microsatellite stable mCRC, with Roche trialling Tecentriq in combination with its MEK inhibitor Cotellic in this patient group (clinicaltrials.gov NCT02788279).

Preclinical studies of additional immunotherapy combinations

Viralytics is also undertaking preclinical studies to assess Cavatak in combination with other immunotherapy agents such as LAG-3, TIM-3 and IDO. It has already shown that the triple combination of Cavatak plus an anti-PD1 antibody and an IDO inhibitor significantly reduced overall mouse tumour burden compared to anti-PD1/IDO inhibitor combination.

These studies could add value as Cavatak advances towards a potential licencing, partnering or sale transaction, by expanding its commercial opportunity across a range of disease indications and drug combinations.

Valuation

We lift our valuation of Viralytics to A$469m or A$1.95/share (undiluted) from A$408m or A$1.70/share. This reflects the following changes:

following the announcement of plans for new Phase Ib Cavatak combination trials in additional indications, we have added risk-adjusted revenue streams in mCRC and HNSCC, and have removed the prostate cancer indication as the development of this indication appears to be a lower priority. For HNSCC we apply a 15% probability of success, in line with the other Phase I programs. For mCRC we apply a 10% probability of success because checkpoint inhibitors have not been shown to be effective as single agents in microsatellite stable disease, which makes this a higher-risk study in our view;

we pushed back assumed Cavatak licence deal timing and melanoma launch date by 12 months to 2019 and 2022 respectively; and

we have rolled forward the DCF model for the new financial year (2018).

Our valuation uses a risk-adjusted net present value (rNPV) method to discount future cash flows for the cancer indications shown in Exhibit 12 through to 2044, using a 12.5% discount rate. It assumes a partnering deal or out-licensing Cavatak in 2019 (previously 2018), with the costs of subsequent clinical development borne by the partner/licensee.

Our model includes risk-adjusted upfront payments and clinical, regulatory and sales milestones from a potential licensing deal, based on average Phase II deal metrics from BioCentury (US$25m upfront payment, US$240m total milestones) and our own assessment of the development stage of Cavatak. There is a broad range of value for deals in the oncolytic virus field, from the US$236m Boehringer Ingelheim/Vira Therapeutics deal for a drug that is still in preclinical development and the December 2016 licence deal between Bristol-Myers Squibb and the unlisted British biotech PsiOxus for its preclinical armed oncolytic virus NG-348 (US$50m upfront, and up to $886m in development, regulatory and sales-based milestones), to $1bn ($425m cash upfront and $575m earnout) of the Amgen/BioVex deal for Phase III asset, T-Vec. We maintain our previous assumption that milestone payments for a Cavatak licence deal will total US$355m as the product is generating favourable clinical data, and advancing towards pivotal development.

Exhibit 13: Viralytics rNPV valuation

Value driver

Unrisked NPV (A$m)

Probability of success

rNPV
(A$m)

rNPV per share (A$)

Key assumptions

Cavatak in metastatic melanoma

745.0

40%

298.0

1.24

Launch in 2022, with peak market penetration of 30% five years after launch. Peak global sales of US$1.0bn.


Assumes simultaneous product launches in US, Europe and RoW; average price of drug US$75k in US and US$45k elsewhere.

One cycle of treatment per patient.

Out-licensing in 2019 with all development costs borne by licensee and a 15% royalty on sales due to Viralytics.

Cavatak in NSCLC

565.5

15%

84.8

0.35

Launch in 2023, with peak market penetration of 5% five years after launch. Peak global sales of US$950m.

Cavatak in metastatic bladder cancer

76.2

15%

11.4

0.05

Launch in 2023, with peak market penetration of 5% five years after launch. Peak global sales of US$130m.

Cavatak in mCRC liver metastases

403.5

10%

40.4

0.17

Launch in 2025, with peak market penetration of 10% five years after launch. Peak global sales of US$850m.

Cavatak in HNSCC

44.3

15%

6.6

0.03

Launch in 2025, with peak market penetration of 5% five years after launch. Peak global sales of US$50m.

Intravesical Cavatak in NMI bladder cancer

107.6

15%

16.1

0.07

Launch in 2024, with peak market penetration of 10% five years after launch. Peak global sales of US$185m, assuming average price of drug US$10k in US market, and global sales 2x US sales. 15% royalty on sales due to Viralytics.

Milestones

281.1

50-35%

118.2

0.49

US$35m upfront payment (50% risk adjustment); US$20m milestones on Phase III start, US$40m filing, US$120m on approval and US$175m sales related milestones (40% risk adjusted).

R&D expenses (net of rebate)

(20.8)

(20.8)

(0.09)

 

 

Admin

(43.2)

100-10%

(19.0)

(0.08)

 

 

Tax

(408.8)

(101.4)

(0.42)

Australian corporate tax of 30%

 

Portfolio total

1,750.6

434.4

1.81

Net cash (end FY17)

34.3

0.14

 

 

Total

468.7

1.95

 

 

Source: Edison Investment Research

Sensitivities: Trial results and partnering key risks

Viralytics is subject to typical biotech company development risks, including the unpredictable outcome of trials, regulatory decisions, success of competitors, financing and commercial risks. In particular, it has a very high single-product risk, with its entire value residing in Cavatak. The investment case hinges on the outcome of clinical trials and the company’s ability to secure a partnership (or further capital) to advance Cavatak into late-stage trials. Ideally, a partner would have the resources to evaluate Cavatak in multiple cancer indications. The greatest commercial opportunity for Cavatak is likely to be in combination with checkpoint inhibitors or other targeted agents – outcomes of ongoing Phase Ib combination trials could be critical to future clinical and commercial success.

Financials

Viralytics reported a loss of A$12.3m in FY16 (A$11.6m when foreign currency translation loss is excluded). R&D expenses for FY17 totalled A$13.5m vs A$8.6m in FY16, reflecting increased clinical development activities. A rebate of A$4.3m was received in Q317 under the Australian government’s R&D incentive scheme, and A$6.5m is expected in FY18. We lift forecast R&D expenditure to A$13.5m in FY18, to match the increased expenditure in FY17. We do not include the foreign exchange translation gain or loss in our financial summary (Exhibit 13). Cash at 30 September of A$27.7m is sufficient to fund operations beyond the end of FY18 in our forecasts. We model a partner funding a significant proportion of R&D costs in FY19, but do not included any upfront or milestone payments from a potential licensing deal in FY19 in our financial forecasts.


Exhibit 14: Financial summary

A$'000s

2015

2016

2017

2018e

2019e

30-June

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

2,454

4,655

6,480

5,873

6,090

R&D expenses

(5,925)

(8,604)

(13,493)

(13,500)

(14,000)

SG&A expenses

(2,568)

(4,515)

(4,729)

(4,729)

(4,729)

EBITDA

 

 

(6,040)

(8,464)

(11,742)

(12,357)

(12,639)

Operating Profit (before amort. and except.)

 

(6,074)

(8,501)

(11,794)

(12,453)

(12,760)

Intangible Amortisation

(390)

(390)

(390)

(390)

(390)

Exceptionals

0

0

0

0

0

Other

0

0

0

0

0

Operating Profit

(6,465)

(8,891)

(12,184)

(12,843)

(13,150)

Net Interest

527

508

543

411

280

Profit Before Tax (norm)

 

 

(5,547)

(7,993)

(11,250)

(12,042)

(12,480)

Profit Before Tax (FRS 3)

 

 

(5,938)

(8,383)

(11,641)

(12,432)

(12,870)

Tax

0

0

0

0

0

Profit After Tax (norm)

(5,547)

(7,993)

(11,250)

(12,042)

(12,480)

Profit After Tax (FRS 3)

(5,938)

(8,383)

(11,641)

(12,432)

(12,870)

Average Number of Shares Outstanding (m)

184.0

212.2

240.3

240.3

240.3

EPS - normalised (c)

 

 

(3.0)

(3.8)

(4.7)

(5.0)

(5.2)

EPS - normalised fully diluted (c)

 

 

(3.0)

(3.8)

(4.7)

(5.0)

(5.2)

EPS - (IFRS) (c)

 

 

(3.2)

(3.9)

(4.8)

(5.2)

(5.4)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

2,116

1,722

1,400

1,033

643

Intangible Assets

2,034

1,643

1,253

863

473

Tangible Assets

82

79

147

170

170

Investments

0

0

0

0

0

Current Assets

 

 

24,441

50,970

41,139

30,157

17,678

Stocks

0

0

0

0

0

Debtors

2,875

4,849

6,865

6,865

6,865

Cash

21,566

46,121

34,274

23,292

10,813

Other

0

0

0

0

0

Current Liabilities

 

 

(1,685)

(2,364)

(2,949)

(2,949)

(2,949)

Creditors

(1,685)

(2,364)

(2,949)

(2,949)

(2,949)

Short term borrowings

0

0

0

0

0

Long Term Liabilities

 

 

0

0

0

0

0

Long term borrowings

0

0

0

0

0

Other long term liabilities

0

0

0

0

0

Net Assets

 

 

24,872

50,328

39,590

28,241

15,371

CASH FLOW

Operating Cash Flow

 

 

(5,010)

(8,050)

(11,953)

(12,356)

(12,639)

Net Interest

544

508

543

411

280

Tax

0

0

0

0

0

Capex

(69)

(33)

(120)

(120)

(120)

Acquisitions/disposals

0

0

0

0

0

Financing

40

30,799

336

0

(0)

Dividends

0

0

0

0

0

Net Cash Flow

(4,495)

23,224

(11,194)

(12,065)

(12,479)

Opening net debt/(cash)

 

 

(24,336)

(21,566)

(46,121)

(34,274)

(23,292)

HP finance leases initiated

0

0

0

0

0

Other

1,725

1,331

(654)

1,083

0

Closing net debt/(cash)

 

 

(21,566)

(46,121)

(34,274)

(23,292)

(10,813)

Source: Company data, Edison Investment Research

Contact details

Revenue by geography

Suite 305, Level 3
66 Hunter Street
Sydney 2000
Australia
+61 2 9988 4000
www.viralytics.com/

N/A

Contact details

Suite 305, Level 3
66 Hunter Street
Sydney 2000
Australia
+61 2 9988 4000
www.viralytics.com/

Revenue by geography

N/A

Management team

CEO: Dr Malcolm McColl

CSO: Professor Darren Shafren

Dr McColl has been CEO since January 2013. He was previously VP business development at Starpharma and responsible for partnering activities and programmes. Other roles include director of business development for Hospira (formerly Mayne Pharma) and CSL, where he was global VP of business development for the Animal Health division.

Dr Shafren is associate professor of virology in the faculty of health, University of Newcastle, and the inventor of the technology acquired by Viralytics. He is responsible for research, development and intellectual property management.

CFO: Robert Vickery

Director – Regulatory Affairs: Dr Jennifer Rosenthal

Mr Vickery is a chartered accountant with over 20 years’ experience in industry and professional practice. During the past decade he has held senior finance roles with several biotech and innovation-based businesses.

Dr Rosenthal has more than 20 years’ experience in the biotechnology sector where she has successfully managed teams and projects in the areas of clinical programme management and regulatory affairs. Prior to joining Viralytics in 2015 she was director of clinical and regulatory affairs at Alchemia where she was responsible for the management of the company’s HyACT platform, including a Phase III trial of lead oncology product HA-Irinotecan.

Management team

CEO: Dr Malcolm McColl

Dr McColl has been CEO since January 2013. He was previously VP business development at Starpharma and responsible for partnering activities and programmes. Other roles include director of business development for Hospira (formerly Mayne Pharma) and CSL, where he was global VP of business development for the Animal Health division.

CSO: Professor Darren Shafren

Dr Shafren is associate professor of virology in the faculty of health, University of Newcastle, and the inventor of the technology acquired by Viralytics. He is responsible for research, development and intellectual property management.

CFO: Robert Vickery

Mr Vickery is a chartered accountant with over 20 years’ experience in industry and professional practice. During the past decade he has held senior finance roles with several biotech and innovation-based businesses.

Director – Regulatory Affairs: Dr Jennifer Rosenthal

Dr Rosenthal has more than 20 years’ experience in the biotechnology sector where she has successfully managed teams and projects in the areas of clinical programme management and regulatory affairs. Prior to joining Viralytics in 2015 she was director of clinical and regulatory affairs at Alchemia where she was responsible for the management of the company’s HyACT platform, including a Phase III trial of lead oncology product HA-Irinotecan.

Principal shareholders

(%)

BVF Partners

8.3

Quest Asset Partners

6.4

Cormorant Global Healthcare Master Fund

6.2

The Capital Group Companies, Inc.

5.8

JCP Investment Partners

5.1

Companies named in this report

Merck, BMS, AstraZeneca, Roche, Amgen, Boehringer Ingelheim

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 Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. 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 Viralytics 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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

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

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 Pty Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. 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 Viralytics 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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

JPMorgan European Smaller Companies Trust — Very strong performance track record

JPMorgan European Smaller Companies Trust (JESC) was launched in 1990 and aims to generate long-term capital growth from a diversified portfolio of small-cap European equities. The investment process involves screening the c 1,500 company universe to construct a relatively concentrated portfolio of 50-75 positions in firms with positive fundamentals and reasonable valuations. JESC has a very good investment track record, outperforming its benchmark over one, three, five and 10 years. It has also performed strongly versus the average of its four peers, ranking second over one, three and five years and first over the last 10 years, where its NAV total return is 23.6pp higher than its closest peer.

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