International Stem Cell — Update 14 December 2016

International Stem Cell — Update 14 December 2016

International Stem Cell

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International Stem Cell

Phase I progressing

Financial update

Pharma & biotech

14 December 2016

Price

US$1.33

Market cap

US$5m

Net cash ($m) at 30 September 2016

0.7

Shares in issue

3.6m

Free float

55%

Code

ISCO

Primary exchange

OTC

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(26.1)

(29.6)

(69.2)

Rel (local)

(29.6)

(34.1)

(72.7)

52-week high/low

US$5.0

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

Phase I preliminary data

Q117

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 that the first two patients in its Phase I trial in Parkinson’s disease (PD) had successfully undergone intracranial transplants of ISC-hpNSC without complications. The study will enroll 12 patients at three dosing regimens with a primary endpoint of safety, but will provide preliminary efficacy data measured at six and 12 months following the treatment.

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/14

7.0

(8.7)

(9.71)

0.0

N/A

N/A

12/15

7.6

(4.6)

(1.29)

0.0

N/A

N/A

12/16e

7.5

(4.8)

(1.26)

0.0

N/A

N/A

12/17e

8.3

(6.0)

(1.57)

0.0

N/A

N/A

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

Parkinson’s trial ongoing

Patients on the study will be treated with 30m to 70m stem cells, delivered via intracranial injection. The single-arm, open-label study is being conducted at the Royal Melbourne Hospital in Australia. Clinical assessments are scheduled at six and 12 months following surgery, and the data from this trial will be used in the design of a future Phase II trial expected to initiate in late 2017 or 2018.

Trial will provide first evaluation of efficacy

Besides safety, the trial will also provide physiological and functional assessments of the patients, which will give the first indication of the efficacy of the treatment in humans. Brain function will be directly assessed via PET scan to assess the degree of disease progression. Additionally, patients will be assessed via the six-point Unified Parkinson Disease Rating Scale (UPDRS), a qualitative functional scale of a patient’s mental state, muscle tone and ability to perform daily tasks.

Preclinical safety studies published

In the 30 September issue of Scientific Reports, a journal from the publishers of Nature, data from in vitro and in vivo preclinical studies showed that the company’s ISC-hpNSC cells are devoid of undifferentiated pluripotent stem cells and are safe for transplantation due to the low risk of tumorigenicity. In another preclinical study, ISC-hpNSC cells improved cognitive performance and motor coordination in rodents with traumatic brain injury.

Valuation: $24m or $7.57 per basic share

We have decreased our valuation from $28m or $8.75 per basic share to $24m or $7.57 per basic share. This is primarily due to a lower value for the cosmetic business, due to lower than expected revenues, as well as a lower cash balance and a higher share count. There remain approximately 17.9m potentially dilutive shares from warrants, options and convertible preferred stock. We project that the company will need at least $73m (previously $76m) in additional financing before profitability in 2024, of which $10.5m will be required by the end of 2017.

ISC-hpNSC for Parkinson’s disease

International Stem Cell Corporation has announced that the first two patients in its Phase I trial in Parkinson’s disease (PD) have successfully undergone intracranial transplant of ISC-hpNSC without complications. It had initiated the Phase I trial of ISC-hpNSC for the treatment of PD in July. 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 between 30m and 70m cells. The trial will also evaluate the treatment for efficacy by monitoring changes in brain function via PET scan, as well as functional assessment via the UPDRS over the course of 12 months. The study is being performed at the Royal Melbourne Hospital in Australia and has a targeted enrolment of 12 moderate to severe PD patients.

The UPDRS is the most common standardized assessment used to monitor the progression and severity of PD in the clinical setting. It comprises six sections, including both patient and clinician evaluation of motor function, mood and the ability to perform daily tasks (Exhibit 1).

Exhibit 1: Unified Parkinson Disease Rating Scale

Section

Description

Assessments

1

Mental assessment

Intellectual impairment, thought disorder, depression and initiative

2

Patient scored evaluation of ability to perform daily activities

Hygiene, food preparation, dressing, avoiding falls, speech, tremor etc

3

Clinician scored motor assessment

Measures of function (tremor, rigidity, posture), functional assessments (ability to rise from a chair, gait, speech) and evaluation of specific muscle groups (fingers, face, legs)

4

Complications associated with therapy

Rate of dyskinesia, assessments of “off” periods, other complications of treatment (nausea, insomnia, etc)

5

The Modified Hoehn Yahr Staging

Global evaluation ranging from no visible signs of disease to wheelchair-bound state

6

Schwab & England Activities of Daily Living Scale

Degree of independence from care givers ranging from completely independent to inability to swallow or perform bowel movements

Source: National Parkinson Foundation

The data from this trial will provide the first assessment of ISC-hpNSC in humans. However, the treatment was previously studied in non-human primates (Exhibit 2). In this model, the treatment successfully increased the number of dopaminergic neurons in the animals’ brains measured post-mortem. This was accompanied by an increase in the concentration of free dopamine (up to approximately 200% dependent on brain region), indicating that the neurons were functional. Finally, the animals treated with ISC-hpNSC showed statistically significant improvement over the control animal on an assessment of Parkinsonian symptoms (ParkScore).

Exhibit 2: ISCO preclinical data

Source: International Stem Cell presentation

PD affects 7-10 million people worldwide, with approximately 1.5 million in the US. The most widespread treatment for the disease is the combination of levodopa and carbidopa, which provides the brain with dopamine lost by the death of dopaminergic neurons. The majority of clinical development in the space has been focused on the reformulation of this and other treatment regimens and, to date, no disease-modifying therapies have been approved. A small number of gene and cell therapies focused on changing the course of the disease have entered the clinic (Exhibit 3).

Exhibit 3: Selected clinical-stage cell and gene therapy candidates in PD

Company (originator)

Stage of development

Description

Therapeutic modality

Milestones/comments

Living Cell Technologies

Phase IIa

Choroid plexus cell product that secretes neurotrophins and cerebrospinal fluid (CSF)

Cell therapy

Phase IIb start Q116; NTCELL decreased UPDRS by an average of 16 points after 58 weeks, representing a three- to four-year reversal of neurological deterioration.

International Stem Cell

Phase I

Neuronal cells derived from human parthenogenetic stem cells (hpSC)

Cell therapy: Stem cell

Phase I preliminary data (Q416).

uniQure NV

Phase I

Adeno-associated viral (AAV) vector carrying the glial cell-derived neurotrophic factor (GDNF) gene

Gene therapy: Viral vector: Adeno-associated virus (AAV)

The aim of this clinical trial is to introduce GDNF in a targeted way to the brain to enhance outcomes. NIH research at UCSF with option to license.

Voyager Therapeutics

Phase II

Adeno-associated virus (AAV) serotype 2 encoding the dopa decarboxylase (DDC; AADC) gene injected into the putamen

Gene therapy: Viral vector: Adeno-associated virus (AAV)

Phase Ib data (H216).

Oxford BioMedica

Phase I/II

LentiVector carrying three genes encoding enzymes for dopamine synthesis

Gene therapy: Viral vector: Lentivirus

Preclinical studies in the industry standard in vivo model of Parkinson’s disease have shown that, following a single treatment, almost complete recovery of movement behavior was achieved after five to eight weeks. Therapeutic effect was statistically significant (p<.0.05) after two weeks and was maintained throughout the duration of the preclinical studies, with the latest time point being 44 months.

Source: BioCentury, Edison Investment Research

The announcement that the first two patients have been dosed in this trial is consistent with our previously predicted timeline. We currently expect that the company will be able to progress to a Phase II study in late 2017 or 2018 depending on the safety and efficacy profile discovered in the current trial (preparations may begin at the six-month interim update if early efficacy is seen, or later if the maximum tolerable dose is not reached early); however, we do not expect preliminary data until Q117 (previously Q416). We currently model commercialization of the product in 2024.

Valuation

We have decreased our valuation from $28m or $8.75 per basic share to $24m or $7.57 per basic share. This is primarily due to a lower value for the cosmetic business due to lower than expected revenues, as well as a lower cash balance and a higher share count. There remain approximately 17.9m potentially dilutive shares from warrants, options and convertible preferred stock.

Exhibit 4: Risk-adjusted NPV valuation model

Product

Status

Launch

Peak sales ($m)

NPV
($m)

Probability

rNPV
($m)

NPV/share ($/share)

Cosmetic and biomedical business

Commercial

Current

22

26

90%

24

7.38

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

Phase I/IIa

2024

2,800

408

7.5%

31

9.58

G&A expenses – after tax

100%

(31)

(9.62)

Net cash (at end Q316)

0.7

100%

0.7

0.48

Valuation

 

 

 

435

 

24

7.57

Source: Edison Investment Research estimates

Financials

International Stem Cell reported revenues of $1.9m for Q316, down 9% compared to Q315. This decline was due to weakness in the cosmetic business, which reported sales of $0.65m for the quarter, down 30% compared to the same quarter last year. The reason for this weakness has not been disclosed, but the company has said previously that the cosmetic business is non-core and it would limit investments in that area. The biomedical business continues to grow, reporting revenues of $1.3m in Q316, up 7% compared to Q315. For the company as a whole, the operating loss was $1.3m. We have adjusted our model to reflect weaker cosmetic business sales than we had forecast as well as lower R&D spending in 2016 thus far.

Exhibit 5: Changes to estimates

$000s

Revenue

Operating profit

Profit after tax

Old

New

% change

Old

New

% change

Old

New

% change

2016e

8,167

7,471

(8.5%)

(5,052)

(4,803)

4.9%

(5,532)

(4,803)

13.2%

2017e

9,043

8,311

(8.1%)

(4,746)

(5,130)

(8.1%)

(5,826)

(5,970)

(2.5%)

2018e

9,924

9,156

(8.4%)

(6,339)

(6,749)

(6.5%)

(8,019)

(8,189)

(2.1%)

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

We project the company will need at least $73m (previously $76m) in additional financing before profitability in 2024, of which $10.5m will be required by the end of 2017, which we record as illustrative debt in Exhibit 6.

Exhibit 6: Financial summary

US$000

2013

2014

2015

2016e

2017e

2018e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

6,150

7,017

7,551

7,471

8,311

9,156

Cost of Sales

(1,643)

(1,921)

(2,056)

(2,017)

(2,244)

(2,381)

Gross Profit

4,507

5,096

5,495

5,454

6,067

6,776

Research and development

(3,560)

(5,386)

(2,707)

(2,800)

(4,000)

(6,000)

EBITDA

 

 

(8,007)

(9,138)

(5,036)

(5,131)

(5,458)

(7,077)

Operating Profit (before amort. and except.)

(7,543)

(8,680)

(4,564)

(4,803)

(5,130)

(6,749)

Intangible Amortization

0

0

0

0

0

0

Exceptionals

0

0

0

1,676

0

0

Other

(2,930)

(3,796)

1,929

0

0

0

Operating Profit

(10,473)

(12,476)

(2,635)

(3,127)

(5,130)

(6,749)

Net Interest

(3)

(2)

0

0

(840)

(1,440)

Profit Before Tax (norm)

 

 

(7,546)

(8,682)

(4,564)

(4,803)

(5,970)

(8,189)

Profit Before Tax (reported)

 

 

(10,476)

(12,478)

(2,635)

(3,127)

(5,970)

(8,189)

Tax

0

0

0

0

0

0

Profit After Tax (norm)

(10,476)

(12,478)

(2,635)

(4,803)

(5,970)

(8,189)

Profit After Tax (reported)

(10,476)

(12,478)

(2,635)

(3,127)

(5,970)

(8,189)

Average Number of Shares Outstanding (m)

0.8

1.3

2.0

3.8

3.8

3.8

EPS - normalised (US$)

 

 

(12.77)

(9.71)

(1.29)

(1.26)

(1.57)

(2.16)

EPS - normalised fully diluted (US$)

 

 

(12.77)

(9.71)

(1.29)

(1.26)

(1.57)

(2.16)

EPS - (reported) (US$)

 

 

(12.77)

(9.71)

(1.29)

(0.82)

(1.57)

(2.16)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

73.3

72.6

72.8

73.0

73.0

74.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

3,113

3,563

4,147

4,835

5,429

6,040

Intangible Assets

2,250

2,795

3,223

3,815

4,407

4,999

Tangible Assets

830

714

864

960

962

981

Investments

33

54

60

60

60

60

Current Assets

 

 

4,626

3,616

2,991

4,965

6,922

6,644

Stocks

1,369

1,517

1,348

1,334

1,484

1,635

Debtors

306

453

539

533

593

654

Cash

2,243

1,111

532

2,526

4,273

3,784

Other

708

535

572

572

572

572

Current Liabilities

 

 

(7,021)

(6,858)

(5,544)

(7,255)

(7,377)

(7,499)

Creditors

(7,021)

(6,858)

(5,544)

(7,255)

(7,377)

(7,499)

Short term borrowings

0

0

0

0

0

0

Long Term Liabilities

 

 

0

0

0

(3,000)

(10,500)

(18,000)

Long term borrowings

0

0

0

(3,000)

(10,500)

(18,000)

Other long term liabilities

0

0

0

0

0

0

Net Assets

 

 

718

321

1,594

(455)

(5,525)

(12,815)

CASH FLOW

Operating Cash Flow

 

 

(5,635)

(6,413)

(4,120)

(4,212)

(3,991)

(5,610)

Net Interest

(3)

(2)

0

0

(840)

(1,440)

Tax

0

0

0

0

0

0

Capex

(896)

(988)

(738)

(1,016)

(922)

(939)

Acquisitions/disposals

0

0

0

0

0

0

Financing

8,123

6,270

1,169

3,519

0

0

Dividends

0

0

0

0

0

0

Net Cash Flow

1,589

(1,133)

(3,689)

(1,709)

(5,753)

(7,989)

Opening net debt/(cash)

 

 

(654)

(2,243)

(1,111)

(532)

474

6,227

HP finance leases initiated

0

0

0

0

0

0

Other

0

1

3,110

703

0

0

Closing net debt/(cash)

 

 

(2,243)

(1,111)

(532)

474

6,227

14,216

Source: International Stem Cell accounts, Edison Investment Research

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by 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 Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
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Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

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Copyright 2016 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 Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
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Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Sunesis Pharmaceuticals — Update 13 December 2016

Sunesis Pharmaceuticals

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