4SC — Domatinostat R&D ramp-up in H218

4SC — Domatinostat R&D ramp-up in H218

During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).

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Written by

4SC

Domatinostat R&D ramp-up in H218

Q218 update

Pharma & biotech

17 August 2018

Price

€4.02

Market cap

€123m

Net cash (€m) at 30 June 2018

34.1

Shares in issue

30.6m

Free float

35%

Code

VSC

Primary exchange

Frankfurt (Xetra)

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(5.3)

(31.3)

(7.1)

Rel (local)

(2.8)

(27.0)

(6.9)

52-week high/low

€8.5

€3.8

Business description

4SC is a Munich-based cancer biopharmaceutical company. Resminostat (HDAC inhibitor) is the lead candidate for cutaneous T-cell lymphoma (CTCL, pivotal study started in Q416). It has a second compound, domatinostat (Phase Ib/II started in Q317) and a preclinical asset, 4SC-208. 4SC also has several partners including Yakult Honsha for resminostat in Japan in various indications.

Next events

Initiation of EMERGE study

H218

R&D update on domatinostat combination studies

H218

Top-line data from SENSITIZE study (cohort 1)

H218

Top-line data from RESMAIN study

H219

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

4SC is a research client of Edison Investment Research Limited

During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/16

2.1

(10.9)

(0.54)

0.0

N/A

N/A

12/17

4.2

(10.0)

(0.41)

0.0

N/A

N/A

12/18e

4.7

(17.6)

(0.57)

0.0

N/A

N/A

12/19e

3.1

(19.2)

(0.63)

0.0

N/A

N/A

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

Domatinostat combo strategy revealed late 2018

With current funds, management plans to initiate at least two additional checkpoint combination studies, which will include the pivotal MCC study and the Phase II skin cancer checkpoint combination study (lead-in for the MCC study). Further detail will be provided to investors later in 2018. We expect 4SC’s domatinostat programme to become more significant in H218 with multiple catalysts in the period: publication of a data set from the SENSITIZE study (first dose cohort) including safety, efficacy and biological data; initiation of the EMERGE study; fresh preclinical checkpoint combination data; and initiation of an additional combination study.

Financials

In H118 the average cash burn was €1.2m/month, while management’s FY18 guidance stays at €1.8-2.0m/month, indicating increased cash burn in H218. For Q218, R&D costs were €4.3m vs €2.2m in Q217. We expect R&D costs to ramp up in H218 reflecting domatinostat trials. Net cash as of 30 June 2018 was €34.1m. 4SC continues to guide cash reach into 2020, providing a number of R&D catalysts.

Valuation: Reduced slightly to €10.7/share

We lower our rNPV-based valuation to €327m, or €10.7/share, from €348m (€11.4/share), due to the updated valuation for resminostat CTCL. We now expect resminostat to launch in 2021 vs 2020 following the announced modest delay in top-line data from the RESMAIN study, which are now due in H219 vs H119. A key near-term catalyst is first interim data from the SENSITIZE study (H218).

Domatinostat combination strategy to be revealed soon

As described in our previous note, 4SC intends to carry out a broad clinical programme for domatinostat, beyond SENSITIZE and EMERGE, involving combination studies with checkpoint inhibitors to tackle the high non-responder issue. As of the last update by 4SC, these additional combination studies included a pivotal study in MCC in combination with avelumab, and several other Phase II combination and triple combination studies that were not defined. In the Q218 update, management explained that while these plans are still subject to discussion, it could confirm the company has sufficient capital to initiate ‘some’ of these additional studies (bearing in mind it has available capital into early 2020), and this will ‘certainly’ include the MCC pivotal study and a Phase II skin cancer checkpoint combination study. The skin cancer study would be a ‘run in’ to the pivotal study for MCC. Management aims to release further detail on these studies to investors at the end of 2018. During the Q&A session, 4SC also expressed interested in exploring further new double and triple combinations with domatinostat together with partners.

According to the Q218 update, the SENSITIZE study (domatinostat Phase Ib/II melanoma study in combination with pembrolizumab) is on track with enrolment in Europe, where the second cohort has started treatment following a positive safety review from the first cohort. The company will publish a data set including safety, efficacy and biological data from the first dose cohort in H218, and top-line data from the whole study are expected in H119. Now the FDA has approved 4SC’s IND application for domatinostat in melanoma (announced 15 August 2018), it is likely the SENSITIZE study trial will include US trial centres from 2019. Meanwhile, the EMERGE study (domatinostat Phase II MSS GI cancer) is expected to enrol the first patient in Q318. Safety data are expected in Q119 and early efficacy data in H219.

Overall, we see a strong interest and commitment from management to develop the domatinostat pipeline in both Europe and the US, with emphasis on the domatinostat checkpoint combinations.

Mogamulizumab: FDA approval positive for resminostat?

On 8 August 2018, the FDA approved a new drug for CTCL Poteligeo (mogamulizumab, Kyowa Kirin, Inc), which had previously been granted FDA priority review, breakthrough status and Orphan Drug designation. Mogamulizumab is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. It is already approved in Japan and is expected to be approved in Europe in December 2018 (EvaluatePharma).

Management believes this news is positive for resminostat, since it demonstrates that the FDA is accepting PFS as an endpoint in CTCL, which is also used as the primary endpoint in the RESMAIN study. Secondly, it demonstrates that HDAC inhibitors are unsuitable for use as a monotherapy for reducing tumour burden in progressive patients. This is because the mogamulizumab trial was compared with HDACi vorinostat, which was only able to achieve 3.1 months PFS compared with 7.6 months with mogamulizumab.

The two drugs are not expected to compete directly since mogamulizumab is targeting relapsed or refractory patients and resminostat is targeting patients who have at least achieved disease control after a previous treatment, although they are both targeting the same subtypes of CTCL (mycosis fungoides and Sézary syndrome). Patients are being enrolled into the RESMAIN study if they have achieved either complete response, partial response or stable disease with previous systemic therapy. According to management, previous systemic therapy would also include mogamulizumab and so these patients would also be eligible for maintenance treatment with resminostat. Following this logic, if mogamulizumab shows good efficacy in the clinic, it could increase the number of patients achieving at least disease control, thus increasing the number of patients eligible to move onto maintenance with resminostat, and possibly also increase the number of months of treatment with resminostat. It is too early to see how this will shape in clinical practice, however, the rationale appears to be sound.

4SC has been gathering further pre-clinical data to support the unique positioning of resminostat in the maintenance setting. A recent and interesting finding is that resminostat modulates progression-associated genes in CTCL cell lines (Exhibit 1). Management believe these new data support the idea that resminostat can prolong time to progression for CTCL patients.

Exhibit 1: RNA-seq gene expression analysis shows down-regulation of progression-associated genes in resminostat-treated CTCL cell lines compared with control (DMSO)

Source: 4SC Poster Presentation. Note: CTCL cell lines = My-La CD4+, HH and HuT78, ctrl = control (DMSO), res = resminostat.

4SC aims to enrol at least 100 patients in 2018 (previously 150) to the RESMAIN study. Since joining the study in H118, Yakult has five active clinical centres, and has recruited four patients from two of these centres. The company does not have a target for enrolment in Japan. Top-line data from the study are now expected in late 2019 (previously H119). Currently this appears a modest delay and could be related to Yakult jumping on board geographically expanding the trial to Japan, but no specific reasons were mentioned by the company. These delays could affect the filing date, which we previously included in our model as 2019. Depending on how late in 2019 data will be available, 4SC might have to file in 2020, which means market launch in 2021 (previously 2020 in our model).

Upcoming newsflow

Exhibit 2: Upcoming newsflow relating to clinical trials and other activities

H218

H119

H219

2020

Resminostat clinical studies

RESMAIN (Pivotal study, CTCL)

Enrolment of at least 100 patients (n=150)

Top-line data expected

Marketing authorisation filing in Europe

Yakult study (Phase II, biliary tract cancer)

Final study results expected by partner Yakult

Domatinostat clinical studies

SENSITIZE (Phase Ib/II, melanoma)

Cohort 2 enrolment expected to complete

Cohort 1 data set published

Cohort 2 data set published

Cohort 3 enrolment expected to complete

Cohort 3 data set published

EMERGE (Phase II, GI cancers)

First patient expected to be enrolled

Safety data published

Early efficacy data published

Domatinostat in Merkel-cell carcinoma

MCC preclinical data to be published

Initiation of MCC Phase II study TBC

Additional domatinostat combination studies

Update on R&D strategy

New preclinical triple combination data to be published

Initiation of additional checkpoint combination studies

Other activities

Out-licensing

Further out-licensing of non-core assets

Fund-raising

Potential new fund-raise (current cash reach into early 2020)

Source: 4SC, Edison Investment Research. Note: Bold indicates key catalysts (efficacy data, marketing authorisation).

Valuation

We revised our valuation of resminostat in CTCL, due to the updated timeline for the RESMAIN pivotal study, as discussed above. Consequently, we have updated our model to reflect market launch in 2021 compared to 2020 before. The rNPV of resminostat CTCL is now €243m (vs €274.2m). All other valuation assumptions remain unchanged. As a result, we have slightly decreased our valuation of 4SC from €348m (€11.4/share) to €327m (€10.7/share). The valuation was also marginally affected by a lower net cash position, offset by rolling the model forward.

Exhibit 3: Financial summary

€'000s

2016

2017

2018e

2019e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

2,060

4,197

4,724

3,133

Cost of sales

(76)

(574)

(574)

(574)

Gross profit

1,984

3,623

4,150

2,559

R&D expenditure

(10,601)

(11,475)

(19,555)

(19,461)

Administrative, distribution and other

(3,175)

(3,084)

(3,195)

(3,289)

Operating profit

(11,792)

(10,936)

(18,600)

(20,191)

Intangible amortisation

(892)

(892)

(892)

(892)

Exceptionals (impairment / restructuring costs)

0

0

0

0

Share-based payments

0

0

(20)

(20)

EBITDA

 

 

(10,900)

(9,819)

(17,463)

(19,054)

Operating Profit (before amort and except.)

 

(10,900)

(10,044)

(17,688)

(19,279)

Net interest

(14)

9

100

100

Other (profit/loss from associates)

711

0

0

0

Profit before tax (norm)

 

 

(10,914)

(10,035)

(17,588)

(19,179)

Profit before tax (FRS 3)

 

 

(11,095)

(10,927)

(18,500)

(20,091)

Tax

(71)

(33)

0

0

Profit after tax (norm)

(10,274)

(10,068)

(17,588)

(19,179)

Profit after tax (FRS 3)

(11,166)

(10,960)

(18,500)

(20,091)

Average Number of Shares Outstanding (m)

19.0

24.8

30.6

30.6

EPS - normalised (c)

 

 

(54.17)

(40.58)

(57.39)

(62.58)

EPS - FRS 3 (€)

 

 

(0.59)

(0.44)

(0.60)

(0.66)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed assets

 

 

7,096

6,365

5,452

4,539

Intangible assets

6,499

5,694

4,806

3,918

Tangible assets

497

570

545

520

Investments and other

100

101

101

101

Current assets

 

 

11,959

41,548

22,957

4,522

Stocks

0

0

0

0

Debtors

95

30

30

30

Cash

10,048

41,327

22,736

4,301

Other current assets

1,816

191

191

191

Current liabilities

 

 

(3,257)

(2,759)

(3,636)

(2,840)

Creditors

(834)

(1,175)

(1,175)

(1,175)

Short-term borrowings

0

0

0

0

Deferred revenue (short term)

(1,431)

(1,485)

(2,362)

(1,566)

Other current liabilities

(992)

(99)

(99)

(99)

Long-term liabilities

 

 

(525)

(461)

(511)

(486)

Long-term borrowings

0

0

0

0

Deferred revenue (long term)

(493)

(394)

(444)

(419)

Other long-term liabilities

(32)

(67)

(67)

(67)

Net assets

 

 

15,273

44,693

24,263

5,735

CASH FLOW

Operating cash flow

 

 

(12,320)

(8,508)

(18,390)

(18,234)

Net interest

(531)

0

3

3

Tax

(71)

(33)

0

0

Capex

(404)

(168)

(200)

(200)

Expenditure on intangibles

(60)

(4)

(4)

(4)

Acquisitions/disposals

2,808

39

0

0

Financing

0

39,953

0

0

Other

650

0

0

0

Net cash flow

(9,928)

31,279

(18,591)

(18,435)

Opening net debt/(cash)

 

 

(19,514)

(10,048)

(41,327)

(22,736)

HP finance leases initiated

0

0

0

0

Other

462

0

0

0

Closing net debt/(cash)

 

 

(10,048)

(41,327)

(22,736)

(4,301)

Source: 4SC, Edison Investment Research

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 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by 4SC 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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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 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by 4SC 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 2018. “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.

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Schumannstrasse 34b

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London +44 (0)20 3077 5700

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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 4, 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 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Sunesis Pharmaceuticals — Interim readout coming up

Sunesis has reported Q2 earnings and provided an update on enrolment in its ongoing dose escalation study of vecabrutinib. It continues to enrol the 50mg cohort and will announce when it is complete. The company also stated that it intended to provide an update on the program at the American Society of Hematology (ASH) meeting in December 2018.

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