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International Stem Cell — Interim Parkinson’s data

International Stem Cell — Interim Parkinson’s data

International Stem Cell recently announced interim six-month results from the first cohort of four patients in its Phase I trial of ISC-hpNSC in Parkinson’s disease (PD). Positive signals were seen in a variety of measures, which include daily living, mobility, depression and compulsive disorders. The trial is continuing and the second cohort is almost enrolled, with the third patient of four recently undergoing surgical implantation. The study will enroll 12 patients at three dosing regimens (30-70m cells).

Analyst avatar placeholder

Written by

International Stem Cell

Interim Parkinson’s data

Clinical update

Pharma & biotech

03 January 2018

Price

US$1.55

Market cap

US$9m

Net debt ($m) at 30 September 2017

2.2

Shares in issue

6.0m

Free float

31.1%

Code

ISCO

Primary exchange

OTC

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(2.5)

(9.9)

50.5

Rel (local)

(4.5)

(15.5)

25.0

52-week high/low

US$1.9

US$0.9

Business description

International Stem Cell is an early-stage biotechnology company developing therapeutic, biomedical and cosmeceutical applications for its proprietary stem form of pluripotent stem cells – human parthenogenetic stem cells (hpSCs). Its lead candidate is a cell therapy treatment for Parkinson’s disease.

Next events

Efficacy data from second cohort

2018

Publication of interim results in scientific journal

2018

Initiation of Phase II in traumatic brain injury

2018

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

International Stem Cell is a research client of Edison Investment Research Limited

International Stem Cell recently announced interim six-month results from the first cohort of four patients in its Phase I trial of ISC-hpNSC in Parkinson’s disease (PD). Positive signals were seen in a variety of measures, which include daily living, mobility, depression and compulsive disorders. The trial is continuing and the second cohort is almost enrolled, with the third patient of four recently undergoing surgical implantation. The study will enroll 12 patients at three dosing regimens (30-70m cells).

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/15

7.6

(4.6)

(1.29)

0.0

N/A

N/A

12/16

7.2

(4.9)

(0.34)

0.0

N/A

N/A

12/17e

7.3

(4.3)

(0.72)

0.0

N/A

N/A

12/18e

8.0

(7.3)

(1.17)

0.0

N/A

N/A

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

Trial in Parkinson’s disease progressing

Patients on the study are being treated in three cohorts with 30m, 50m and 70m stem cells, delivered via intracranial injection. Clinical assessments are scheduled at six and 12 months following surgery, with six-month results recently announced. While early and from a small, single-arm trial, the interim data is encouraging. The seventh patient recently underwent surgical implantation.

Preparing for a Phase II in traumatic brain injury

In September, the company announced that it had completed preclinical studies of ISC-hpNSC in traumatic brain injury (TBI) and was preparing to commence a Phase II trial. According to the Centers for Disease Control, TBI accounts for 2.5 million emergency room visits in the US annually and approximately 3.2-5.3 million people are living with a TBI-related disability.

3D bioprinting of liver cells developed

The company recently announced that it has developed a 3D bioprinter that utilizes proprietary liver progenitor cells that differentiate into different types of liver cells. Once implanted, these could potentially provide a treatment for damaged livers. According to the United Network for Organ Sharing, there are currently over 14,000 on the liver transplant list, but only around 7,800 transplants are performed annually.

Valuation: $33m or $5.52 per basic share

We have updated our valuation to $33m (previously $27m) or $5.52 (previously $6.62) per basic share. The difference is mainly due to lowered expenses, to help conserve cash, rolling forward our NPV and a higher net cash level, mitigated mainly by a higher share count due to the conversion of $2.7m in debt into shares. There remain approximately 14.1m potentially dilutive shares from warrants, options and convertible preferred stock. We project that the company will need at least $62.5m (previously $70m) in additional financing before profitability in 2024, of which a total additional $9m will be required by the end of 2018.

Some positive early signs in Parkinson’s trial

International Stem Cell initiated its Phase I trial of ISC-hpNSC for the treatment of PD in July 2016. ISC-hpNSC are the company’s proprietary neural stem cells (NSC) derived from a human parthenogenetic stem cell line (hpSC). The trial is a dose escalation study designed to evaluate the safety of the intracranial injection of 30m, 50m and 70m cells. The trial is also evaluating the treatment for efficacy by monitoring changes in brain function via PET scan, as well as functional assessment via various measures over the course of 12 months. In November, at the Society for Neuroscience annual meeting in Washington, DC, the company announced interim results from the first cohort of patients, those who received an intracranial injection of 30m cells.

Importantly, there were no serious adverse events reported related to the cells themselves and no evidence of tumors, cysts, enhanced inflammation or infection. Also, there are some early signs of efficacy across a variety of measures (see Exhibit 1), though of course certain caveats apply as this is a single-arm, open-label study, these data are only interim (the key datapoint is 12 months) and no p-values were provided. Additional data on the first cohort may become available upon publication of the interim results in a scientific journal which the company expects to happen sometime in 2018. We await that event as well as data from additional cohorts before updating our valuation for the PD program.

Exhibit 1: Interim data of ISC-hpNSC in PD

Measure

Description

Result at six-month time point

% OFF-Time

% of day when levodopa medication is not performing optimally and PD symptoms return

Decreased 24%

% ON-Time without dyskinesia

% of day that medication is working optimally without dyskinesia

Increased 19%

Beck Depression Inventory

21-question multiple-choice self-report inventory

Improved 35%

Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease

A brief self-completed questionnaire with 15 questions related to impulse control disorders in PD

Decreased 53%

Parkinson’s Disease Quality of Life Score (PDQ-39) - Emotional Wellbeing dimension

The PDQ-39 is a 39-item tool to assess the quality of life in PD patients and is self-completed. The Emotional Wellbeing section consists of 6 items

Improved 33%

PDQ-39 - Activities of Daily Living dimension

6 items in the PDQ-39

Improved 22%

PDQ-39 - Mobility dimension

10 items in the PDQ-39

Improved 15%

PDQ-39 - Bodily Discomfort dimension

3 items in the PDQ-39

Improved 12%

PDQ-39 – Cognitive Impairment dimension

4 items in the PDQ-39

Improved 14%

PDQ-39 - Stigma, Social Support, Communications dimensions

Stigma consists of 4 items, Social Support 3 items and Communications 3 items

Not disclosed

UPDRS during OFF period

The UPDRS is a 6 part rating scale and is the most commonly used scale in the clinical study of PD. It is a qualitative functional scale of a patient’s mental state, muscle tone and ability to perform daily tasks used to follow the course of the disease over time.

No improvement

Change in UPDRS score from baseline

This is a secondary endpoint at 12 months

Not disclosed

Proportion of patients with improvement defined as any reduction in the UPDRS motor score

This is a secondary endpoint at 12 months

Not disclosed

Source: International Stem Cell

Traumatic brain injury Phase II coming soon

International Stem Cell recently announced that it has completed the preclinical studies of ISC-hpNSC in TBI and plans to start a Phase II study of ISC-hpNSC. Once Phase II data are in hand, we would expect the company to apply to the FDA for the new Regenerative Medicine Advanced Therapy (RMAT) designation, which came into existence as part of the 21st Century Cures Act. Sponsors of regenerative medicine products, like ISC-hpNSC, may obtain the designation if the drug is intended to treat a serious or life-threatening condition and there is some preliminary clinical evidence of the ability to address unmet medical needs for that condition. RMAT designation allows for increased interactions with the FDA, similar to the interactions available to those with breakthrough designation, and the company may also become eligible for priority review and accelerated approval.

According to the Centers for Disease Control, TBI accounts for 2.5 million emergency room visits in the US annually and approximately 3.2-5.3 million people are living with a TBI-related disability with no effective long-term treatments outside of rehabilitation. Given the size, TBI could be as meaningful to the company as PD, for which we currently forecast $2.8bn in peak sales. We do not yet include TBI in our valuation as we await more clarity on the start of the company’s Phase II trial.

Valuation

We have updated our valuation to $33m (previously $27m) or $5.52 (previously $6.62) per basic share. The difference is mainly due to lowered expenses, to help conserve cash, rolling forward our NPV and a higher net cash level, mitigated mainly by a higher share count due to the conversion of $2.7m in debt into shares. There remain approximately 14.1m potentially dilutive shares from warrants, options and convertible preferred stock.

Exhibit 2: Risk-adjusted NPV valuation model

Product

Status

Launch

Peak sales ($m)

NPV ($m)

Probability (%)

rNPV ($m)

NPV/share ($)

Cosmetic and biomedical business

Commercial

Current

18

22

90%

20

3.31

Parkinson’s disease (royalties at 12% of sales)

Phase I/IIa

2024

2,800

505

7.5%

38

6.30

G&A expense – after tax

100%

(26)

(4.25)

Net cash

1.0

100%

1.0

0.17

Valuation

 

 

 

528

 

33

5.52

Source: Edison Investment Research estimates

Financials

International Stem Cell reported Q317 revenues of $1.8m, down 4.9% compared to Q316. Through the first nine months of the year, the company reported $5.6m in sales, up 2.5% compared to the same period last year. The biomedical business had revenues of $1.3m in Q317, up 2.7% compared to last year, and is up 21.0% year to date. The cosmetics business, however, was down 20.3% in Q317 and is down 26.4% year to date. For the company as a whole, the operating loss was $1.0m for the quarter, down 22.7% compared to the same quarter last year and down 17.9% for the year, as the profitability of the biomedical business improved to a greater extent than the profitability of the cosmetic business deteriorated. Also, the company was able to reduce its legal and filing fees and investor relations expenses. We have adjusted our model to reflect a weaker commercial business than we had forecast as well as lower R&D and SG&A expenses. The company reported $510,000 in cash and has had an operating cash burn of $183,000 per month this year.

In December, the company announced a note conversion and stock purchase agreement with their CEO. In exchange for the cancellation of a $2.7m note and a cash payment of $500,000 to the company, the CEO was issued 1.86m shares at a conversion and purchase price of $1.75 per share.

Exhibit 3: Changes to estimates

Revenue ($000s)

Operating profit ($000s)

Profit after tax ($000s)

Old

New

% change

Old

New

% change

Old

New

% change

2017e

7,601

7,316

(3.7%)

(4,286)

(4,281)

0.0%

(4,886)

(4,321)

11.6%

2018e

8,343

8,044

(3.6%)

(6,957)

(6,715)

3.5%

(8,157)

(7,315)

10.3%

Source: Edison Investment Research. Note: Operating profit and profit after tax exclude amortization of acquired intangibles, exceptional items and share-based payments.

We project that the company will need at least $62.5m (previously $70m) in additional financing before profitability in 2024, of which an additional $7.5m will be required by the end of 2018.

Exhibit 4: Financial summary

US$000

2015

2016

2017e

2018e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

7,551

7,165

7,316

8,044

Cost of Sales

(2,056)

(1,944)

(1,975)

(2,092)

Gross Profit

5,495

5,221

5,341

5,953

Research and development

(2,707)

(2,856)

(2,800)

(6,000)

EBITDA

 

 

(5,036)

(5,182)

(4,612)

(7,046)

Operating Profit (before amort. and except.)

(4,564)

(4,851)

(4,281)

(6,715)

Intangible Amortisation

0

0

0

0

Exceptionals

0

0

0

0

Other

1,929

3,772

(40)

0

Operating Profit

(2,635)

(1,079)

(4,321)

(6,715)

Net Interest

0

0

0

(600)

Profit Before Tax (norm)

 

 

(4,564)

(4,851)

(4,281)

(7,315)

Profit Before Tax (reported)

 

 

(2,635)

(1,079)

(4,321)

(7,315)

Tax

0

0

0

0

Profit After Tax (norm)

(2,635)

(1,079)

(4,321)

(7,315)

Profit After Tax (reported)

(2,635)

(1,079)

(4,321)

(7,315)

Average Number of Shares Outstanding (m)

2.0

3.2

6.0

6.3

EPS - normalised ($)

 

 

(1.29)

(0.34)

(0.72)

(1.17)

EPS - normalised fully diluted ($)

 

 

(1.29)

(0.34)

(0.72)

(1.17)

EPS - (reported) (US$)

 

 

(1.29)

(0.34)

(0.72)

(1.17)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross Margin (%)

72.8

72.9

73.0

74.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

4,147

4,553

5,165

5,708

Intangible Assets

3,223

3,484

4,032

4,579

Tangible Assets

864

1,011

1,060

1,055

Investments

60

58

74

74

Current Assets

 

 

2,991

2,492

4,050

5,147

Stocks

1,348

1,390

1,306

1,436

Debtors

539

574

522

574

Cash

532

110

1,803

2,719

Other

572

418

418

418

Current Liabilities

 

 

(5,544)

(3,601)

(3,818)

(3,923)

Creditors

(5,544)

(3,601)

(3,818)

(3,923)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

0

0

0

(7,500)

Long term borrowings

0

0

0

(7,500)

Other long term liabilities

0

0

0

0

Net Assets

 

 

1,594

3,444

5,397

(568)

CASH FLOW

Operating Cash Flow

 

 

(4,120)

(4,197)

(666)

(5,111)

Net Interest

0

0

0

(600)

Tax

0

0

0

0

Capex

(738)

(944)

(841)

(874)

Acquisitions/disposals

0

0

0

0

Financing

1,169

4,018

3,200

0

Dividends

0

0

0

0

Net Cash Flow

(3,689)

(1,123)

1,693

(6,585)

Opening net debt/(cash)

 

 

(1,111)

(532)

(110)

(1,803)

HP finance leases initiated

0

0

0

0

Other

3,110

701

0

0

Closing net debt/(cash)

 

 

(532)

(110)

(1,803)

4,781

Source: International Stem Cell accounts, 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 International Stem Cell 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.

Frankfurt +49 (0)69 78 8076 960

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Germany

London +44 (0)20 3077 5700

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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 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by International Stem Cell 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.

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

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Allium Medical Solutions — It is all about business execution

Gardia Medical’s Wirion device is on track for FDA submission, expected by end-2017; approval is possible in Q218. If approved, it would become the only embolic protection system for all atherectomy procedures in the legs which we think will help to reach a strategic transaction. Furthermore, Allium Stents and IBI Medical are expected to gain approval in Russia in 2018 while approval in China is expected in early 2018. We expect initial revenues from Mexico in Q417 and from the strategic agreement in Russia in H118. In addition, Allevetix is due to start a clinical trial in the next few months and TruLeaf is progressing its large animals study. Our updated valuation is NIS1.68/share.

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