Pluristem — New avenues of study

Pluristem — New avenues of study

Pluristem continues to advance its PLX technology platform. In a recent paper it investigated the application of these cells for their ability to inhibit tumor growth; it was found that the cells inhibit growth of a mouse xenograft of a triple-negative breast cancer cell line and induced complete remissions in three out of 10 mice. Additionally, PLX-PAD received approval for an expanded access program from the FDA, allowing it to be used to treat critical limb ischemia (CLI) outside the ongoing Phase III clinical study.

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Pluristem Therapeutics

New avenues of study

Earnings update

Pharma & biotech

28 February 2018

Price*

US$1.45
NIS4.81

Market cap

US$160m
NIS530m

*Priced at 27 February 2018

NIS3.51/$

Net cash ($m) at end Q218

35.86

Shares in issue

110.1m

Free float

93%

Code

PSTI

Primary exchange

NASDAQ

Secondary exchange

TASE

Share price performance

%

1m

3m

12m

Abs

(5.2)

(8.2)

28.3

Rel (local)

(0.8)

(13.0)

10.8

52-week high/low

US$2.0

US$1.1

Business description

Pluristem Therapeutics is a biotech company, headquartered in Israel, focused on the development of cell-based therapeutics derived from placenta. The company is advancing PLX-PAD for critical limb ischemia (CLI) in Phase III and has a Phase III study planned for hip fracture. PLX-R18 is being advanced for acute radiation syndrome and hematopoietic cell transplant.

Next events

FNF IND submission

Coming months

IC Phase II top-line results

Fiscal Q418

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Pluristem continues to advance its PLX technology platform. In a recent paper it investigated the application of these cells for their ability to inhibit tumor growth; it was found that the cells inhibit growth of a mouse xenograft of a triple-negative breast cancer cell line and induced complete remissions in three out of 10 mice. Additionally, PLX-PAD received approval for an expanded access program from the FDA, allowing it to be used to treat critical limb ischemia (CLI) outside the ongoing Phase III clinical study.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

06/16

2.8

(20.2)

(0.25)

0.0

N/A

N/A

06/17

0.0

(24.2)

(0.28)

0.0

N/A

N/A

06/18e

0.0

(28.5)

(0.27)

0.0

N/A

N/A

06/19e

0.0

(45.0)

(0.39)

0.0

N/A

N/A

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

It’s a great time to be a mouse

The recent paper examined the anti-cancer activity of PLX cells induced with tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ) and found they inhibit growth in 26 of 59 cancer cell lines. When a cell line for triple-negative cancer was examined in xenografts, it was found that the cells inhibited growth in vivo and induced complete remission in 3 out of 10 mice. This activity is potentially driven by a reduction in cytokines that promote tumor growth and vascularization.

Expanded access PLX-PAD for CLI

In January 2018, the company announced that the FDA had approved PLX-PAD for its expanded access program, also known as compassionate use. This will allow the treatment to be available to CLI patients with no other options who are not eligible for the ongoing Phase III. We believe that the benign safety record of the treatment contributed to this decision, and the company may be able to use data from these patients to further support its safety and drive future clinical studies.

Q218 results: Expansion of costs

The company reported an operating loss of $8.5m for Q218 ending 30 December 2017. This is a slight increase over the previous period ($7.4m), which we assume is associated with the expansion of the Phase III CLI program. The company guided to completion of the Phase II intermittent claudication (IC) trial in fiscal Q418, which has delayed some expected expenses from the follow-up trial into FY19.

Valuation: Increased to $208m or $1.89/basic share

We have slightly increased our valuation to $208m (from $202m) or $1.89 per basic share. This is largely driven by advancing our NPVs and a delay in the cost of the IC program, offset by an increase in our expected SG&A run rate. We expect to update our valuation with the completion of the Phase II IC trial in fiscal Q418. We forecast that the company will require $50m in additional financing before profitability in 2020.

Preclinical data suggest application in cancer

The company recently published data from a preclinical study on the application for its PLX cell technology outside its current clinical indications for the treatment of cancer. The study found that cells conditioned with tumor necrosis factor alpha (TNF-α) and interferon-gamma (IFN-γ) inhibited tumor growth in 26 of 59 cancer cell lines.1 Additionally, the study went on to investigate one human cell line for triple-negative breast cancer via mouse xenograft (Exhibit 1). Cells from the MDA-MB-231 cell line were injected either subcutaneously or in the mammary fat pad. In both cases there was a significant difference in tumor mass at day 84 (although the treatment schedules were different in each case). The paper further investigated the histology of these tumors, which suggests that the induced PLX cells inhibit proliferation and vascularization. There was a 48% reduction in proliferating cells (p=0.0029) and a 58% reduction in vascularization (as shown by anCD34 staining, p=0.0032). The tumors showed a reduction in the cytokines associated with these processes, although it failed to reach statistical significance compared to untreated tumors.

  Allen H, et al. (2017) Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF-α and IFN-γ Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models. Sci. Rep. 8, 670.

Exhibit 1: Inhibition of mouse xenografts by induced PLX cells

Source: Allen et al. Note: Arrows are PLX cell injections – a) subcutaneous tumor, b) mammary fat pad tumor. *p<0.05.

The results from this study are very interesting and may provide additional avenues for research in the future. However, the study was limited by its exploratory nature. The fact that less than half of the test cell lines responded to the treatment suggests that it may be only narrowly applicable. Moreover, reductions in tumor volume in the xenograft study were modest. This being said, triple-negative breast cancer is notoriously hard to treat, and these results are worth further investigation.

FDA approves expanded access program for PLX-PAD

In January 2018, the FDA accepted the company’s application to allow PLX-PAD to be available to patients through the so-called expanded access program, also known as compassionate use, for the treatment of patients with “no option” critical limb ischemia. The program will allow patients who do not qualify for the ongoing Phase III clinical trial to receive treatment using the cells, and the company may be entitled to remuneration for the cost to produce (although this determination is forthcoming).

We believe the key takeaway from this designation is that the FDA recognizes the innocuous safety profile of the treatment. The criteria for expanded access are that there is evidence of safety and effectiveness and a lack of other treatments. Although these patients cannot be used to support evidence of efficacy for approval (as they are outside clinical trials), they may potentially be used as part of the safety database, as well as to provide insight into particular patient groups worthy of future study.

Valuation

We have slightly increased our valuation to $208m or $1.89 per basic share from $202m or $1.87. This increase is largely driven by advancing our NPVs to the most recent period and a slight delay in the expected costs associated with the IC pivotal trial initiation (based on guidance to Phase II data in Q418). These effects are offset by an increase in unallocated costs associated with an increase in our expected SG&A run rate. We expect to update our valuation with the results from the Phase II IC study, which we believe will also provide insight into the CLI program. We may also add the cancer program to our valuation at a later date if it continues to show promise and is tested in a clinical setting, although we do not expect this in the near term.

Exhibit 2: Valuation of Pluristem

Development program

Prior data

Clinical stage

Prob. of success

Launch year

Launch Pricing ($)

Peak sales ($m)

Patent/Exclusivity Protection

Royalty/
margin

rNPV ($m)

CLI, US

2x Phase I

Phase III

10%

2021

22,500

235

2036

63%

44.57

CLI, Europe

2x Phase I

Phase III

10%

2021

13,500

247

2036

59%

42.30

CLI, Japan

2x Phase I

Phase I/II

20%

2021

22,500

76

2036

27%

9.83

CLI, development costs

(18.94)

FNF (US and Europe)

Phase I for THR

Phase III ready

15%

2021

22,100

171

2036

55%

17.76

ARS

Primate Studies

Pivotal Primate Study

10-20%

2020

N/A

155/
contract

2036

77%

36.86

IC, US

N/A

Phase II

7.5%

2022

11,500

443

2036

57%

38.27

IC, Europe

N/A

Phase II

7.5%

2022

6,900

466

2036

50%

33.94

IC, Japan

N/A

Phase II

15%

2022

11,500

144

2036

20%

7.22

IC, development costs

(31.35)

HCT (US and Europe)

Mouse Studies

Phase I

5%

2023

29,300

239

2036

61%

8.37

Unallocated costs

(16.22)

Total

 

 

 

 

 

 

 

 

172.60

Net cash and equivalents (Q218) ($m)

35.86

Total firm value ($m)

208.46

Total basic shares (m, Q218)

110.1

Value per basic share ($)

1.89

Dilutive warrants

7.62

Diluted firm value ($m)

219.12

Value per diluted share ($)

$1.86

Source: Edison Investment Research, Pluristem company reports

Financials

Pluristem recently reported an operating loss of $8.5m for Q218 ending 31 December 2017. R&D spending for the period was $5.6m, compared to $4.7 in Q1. We assume this increase is associated with the advancement of the Phase III CLI trial and preparations for the Phase III FNF trial. The company guided to results from the Phase II IC study in Q418, which has shifted our spending estimates for this study to later periods. This has resulted in a reduction of our expected FY18 R&D spending estimated to $22.8m from $33.8m, although these costs will be made up in later years. We have increased our expected SG&A spending in 2018 to $10.2m from $7.2m to align with current trends. We expect the company to require $50m in additional capital ($20m in FY18, $30m in FY19, recorded as illustrative debt) to reach profitability in 2020.

Exhibit 3: Financial summary

$000s

2015

2016

2017

2018e

2019e

Year end 30 June

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

379

2,847

0

50

0

Cost of Sales

(13)

(100)

0

(2)

0

Gross Profit

366

2,747

0

48

0

Research and development

(19,173)

(19,580)

(21,092)

(22,754)

(36,267)

Selling, general & administrative

(6,460)

(6,486)

(6,927)

(10,215)

(10,726)

EBITDA

 

 

(27,341)

(25,469)

(30,196)

(34,896)

(48,163)

Operating Profit (before amort. and except.)

(25,267)

(23,319)

(28,019)

(32,878)

(46,993)

Intangible Amortisation

0

0

0

0

0

Exceptionals/Other

0

0

0

0

0

Operating Profit

(25,267)

(23,319)

(28,019)

(32,878)

(46,993)

Net Interest

590

73

205

(1,075)

(3,475)

Other (change in fair value of warrants)

0

0

0

0

0

Profit Before Tax (norm)

 

 

(20,625)

(20,173)

(24,152)

(28,460)

(44,975)

Profit Before Tax (IFRS)

 

 

(24,677)

(23,246)

(27,814)

(33,953)

(50,468)

Tax

0

0

0

0

0

Deferred tax

0

0

0

0

0

Profit After Tax (norm)

(20,625)

(20,173)

(24,152)

(28,460)

(44,975)

Profit After Tax (IFRS)

(24,677)

(23,246)

(27,814)

(33,953)

(50,468)

Average Number of Shares Outstanding (m)

70.3

79.5

87.4

106.5

115.7

EPS - normalised (c)

 

 

(29.35)

(25.36)

(27.63)

(26.72)

(38.88)

EPS - IFRS ($)

 

 

(0.35)

(0.29)

(0.32)

(0.32)

(0.44)

Dividend per share (c)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

11,287

10,345

8,518

6,829

10,862

Intangible Assets

0

0

0

0

0

Tangible Assets

10,173

9,216

7,277

5,537

9,570

Other

1,114

1,129

1,241

1,292

1,292

Current Assets

 

 

56,868

35,596

29,016

42,918

26,235

Stocks

0

0

0

0

0

Debtors

1,691

2,228

1,036

172

172

Cash

53,119

32,750

26,665

41,702

25,019

Other

2,058

618

1,315

1,044

1,044

Current Liabilities

 

 

(6,183)

(5,775)

(5,414)

(6,766)

(9,090)

Creditors

(6,183)

(5,775)

(5,414)

(6,766)

(9,090)

Short term borrowings

0

0

0

0

0

Long Term Liabilities

 

 

(3,829)

(2,010)

(1,869)

(21,975)

(51,975)

Long term borrowings

0

0

0

(20,000)

(50,000)

Other long term liabilities

(3,829)

(2,010)

(1,869)

(1,975)

(1,975)

Net Assets

 

 

58,143

38,156

30,251

21,007

(23,968)

CASH FLOW

Operating Cash Flow

 

 

(20,605)

(18,522)

(21,611)

(24,008)

(41,480)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(831)

(1,750)

(378)

(350)

(5,203)

Acquisitions/disposals

0

0

0

0

0

Financing

17,201

807

15,728

15,837

0

Dividends

0

0

0

0

0

Other

0

0

0

0

0

Net Cash Flow

(4,235)

(19,465)

(6,261)

(8,522)

(46,684)

Opening net debt/(cash)

 

 

(58,819)

(53,119)

(32,750)

(26,665)

(21,702)

HP finance leases initiated

5

0

0

0

0

Exchange rate movements

0

0

0

0

0

Other

(1,470)

(904)

176

3,559

0

Closing net debt/(cash)

 

 

(53,119)

(32,750)

(26,665)

(21,702)

24,981

Source: Company accounts, Edison Investment Research

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US

Sydney+61 (0)2 8249 8342

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Tel Aviv +44 (0)20 3734 1007
Medinat Hayehudim 60

Herzilya Pituach,46766

Israel

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

Tel Aviv +44 (0)20 3734 1007
Medinat Hayehudim 60

Herzilya Pituach,46766

Israel

Research: Investment Companies

Securities Trust of Scotland — Investing globally for sustainable dividend growth

Securities Trust of Scotland (STS) aims to generate rising income and long-term capital growth through investment in quality companies across the globe, with sustainable dividends supported by robust earnings growth. STS appointed a new lead manager in May 2016 and adopted an unconstrained investment approach, allowing the portfolio to reflect the manager’s highest-conviction stock picks in a relatively concentrated portfolio of 35-55 holdings. STS’s performance has since been positive relative to its new peer-based benchmark, while it has a comparable dividend yield of 3.5%, following an increased payout from FY16. It is one of two trusts in the peer group to trade on a discount to cum-income NAV, providing scope for the discount to continue to narrow.

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