Full Phase I data presented at ASCO

Cantargia 13 June 2019 Update
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Cantargia

Full Phase I data presented at ASCO

Q119 update

Pharma & biotech

13 June 2019

Price

SEK17.24

Market cap

SEK1,255m

US$:SEK9.05

Net cash (SEKm) at end Q119 (cash and cash equivalents + short term investments)

251.2

Shares in issue

72.8m

Free float

90%

Code

CANT

Primary exchange

Nasdaq Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.2)

12.0

12.0

Rel (local)

(5.2)

8.1

7.4

52-week high/low

SEK23.3

SEK13.7

Business description

Cantargia is a clinical-stage biotechnology company based in Sweden, established in 2009 and listed on the Nasdaq Stockholm main market. It is developing two antibodies against IL1RAP, nidanilimab (CAN04) and CANxx. Nidanilimab is being studied in a Phase I/II clinical trial, CANFOUR, in solid tumours focusing on NSCLC and pancreatic cancer.

Next events

IND discussions with US FDA

H119

Initiate new US study

H219

Preclinical data supporting combination with platinum-based chemotherapy

2019

Phase IIa CANFOUR data

Early 2020

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

Cantargia presented full data (n=22) from the Phase I part of the CANFOUR study at ASCO on 2 June 2019. These data (safety, biomarker and early efficacy data) were consistent with the interim data presented previously and so did not have an impact on the share price. The recent directed share issue (March 2019) raised SEK106m (gross) primarily from long-term institutional investors. This will fund the Phase IIa part of the CANFOUR study, expansion of the most promising subgroup, initiation of a new US study and efficacy study preparations. Our valuation is slightly higher at SEK2.62bn, but lower on a per share basis at SEK36.0/share.

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/17

0.0

(60.3)

(1.86)

0.0

N/A

N/A

12/18

0.0

(91.2)

(1.38)

0.0

N/A

N/A

12/19e

0.0

(94.6)

(1.36)

0.0

N/A

N/A

12/20e

0.0

(117.8)

(1.62)

0.0

N/A

N/A

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

Full Phase I data confirm CAN04 is safe (n=22)

Cantargia gained useful exposure by presenting its Phase I data as an oral presentation at ASCO. The full data were consistent with interim data previously presented and show that CAN04 is generally well tolerated. The highest dose of 10mg/kg was established and is being used in the Phase IIa. The biomarker data showed a decrease in IL-6 and c-reactive protein (CRP) serum levels following treatment with CAN04. According to Cantargia, this demonstrates target engagement since IL-6 and CRP are markers of disease progression. Although this study was not an efficacy study, Cantargia observed that nine out of 21 patients had stable disease following treatment with CAN04. One patient had seven-month progression-free survival (PFS) and another patient that had five-month PFS.

Financials: SEK106m share issue, cash until H121

With its Q119 results, Cantargia reported an operating loss of SEK23.7m vs SEK15.3m in Q118. This is due to increased R&D costs relating to the Phase IIa part of the CANFOUR study. In March 2019, Cantargia raised SEK106m (gross) in a directed share issue, primarily from long-term institutional investors. This brings the net cash position to SEK251.2m at end-Q119 (including short-term investments). According to our model, this should fund operations into H121 (in line with management guidance). The increased number of shares has lowered EPS slightly, but otherwise we make no changes to our estimates.

Valuation: SEK2.62bn or SEK36.0/share

We value Cantargia at SEK2.62bn or SEK36.0/share vs SEK2.47bn or SEK37.3/share previously. The increase in total NPV is due to rolling our model forward, and higher net cash position following the share issue, with the lower per-share value resulting from the increased number of shares. We make no changes to the assumptions described in detail in our initiation report.

Cantargia is a research client of Edison Investment Research Limited

CANFOUR Phase I data presented at ASCO

Cantargia’s Phase I data were selected for oral presentation at ASCO 2019. It is unusual for such early data to be selected and this provides Cantargia with very useful exposure. Out of 22 patients, 12 had received between three and five prior lines of therapy, nine had received between zero and two prior lines of therapy and one patient had received more than six prior lines of therapy. The majority of patients treated had colorectal cancer (12), followed by pancreatic ductal adenocarcinoma (PDAC) (6) and non-small cell lung cancer (NSCLC) (4). There were no patients with triple-negative breast cancer recruited. There were no treatment-related grade 4/5 adverse events (AEs). 55 AEs were potentially related to CAN04, the most common of which were infusion-related reactions, fatigue, constipation and diarrhoea. Measures were taken to reduce the risk of infusion-related reactions. There were three patients with grade 3 AEs, where the AEs were an infusion-related reaction, hypokalemia, leukopenia and neutropenia. 20 serious adverse events (SAEs) were reported, five of which were considered to be related to CAN04: leukopenia, infusion-related reactions and embolism.

The biomarker data were consistent with the interim data presented at ESMO 2018, where there was a decrease in IL-6 and CRP serum levels following treatment with CAN04. According to Cantargia, this demonstrates target engagement since IL-6 and CRP are markers of disease progression, markers of inflammation and are downstream of IL-1 (CAN04 is targeting IL1RAP which sits within the IL-1 pathway). Although this study was not an efficacy study, Cantargia observed that nine out of 21 patients had stable disease following treatment with CAN04. One patient had seven-month PFS and another patient that had five-month PFS.

In summary, the full Phase I data are consistent with the interim data previously presented and show that CAN04 is generally well tolerated. The highest dose of 10mg/kg was established and is being used in the Phase IIa part of the study.

In addition to this Phase I data, Cantargia recently announced new pre-clinical data that support the chosen combinations with platinum-based chemotherapies and the results will be presented later in 2019. Some of these pre-clinical data in a NSCLC patient-derived xenograft (PDX) model were included in the ASCO presentation, and clearly demonstrate a greater reduction in tumour volume with CAN04 and cisplatin/gemcitabine compared with cisplatin/gemcitabine suggesting synergistic effects (Exhibit 1).

Exhibit 1: Synergistic effects between CAN04 and cisplatin/gemcitabine (pre-clinical)

Next steps: Phase IIa ongoing, results expected in early 2020

During 2019, Cantargia will continue with the Phase IIa part of the CANFOUR study. The focus is on the combination groups in NSCLC and PDAC, while the monotherapy groups are used to support the combination groups, for example by providing biomarker data.

Results from the Phase IIa study are expected in early 2020. If there is a positive signal in one of these patient populations, Cantargia plans to expand the study by enrolling 30–50 additional patients in the most promising subgroup. This would take another 9–12 months (suggesting full enrolment in 2021). Alongside this expansion, the company expects to start preparations for a controlled study in the most promising subgroup. The controlled study would use similar populations as the Phase IIa study, but could be further refined. The design of a potential controlled study is still unclear, since it will be data driven and decided by future meetings with the FDA/EMA. In the meantime, Cantargia plans to start a new US study around Q319. More information will be released on this trial in the summer once the company has met the FDA and submitted an IND.

Valuation

We value Cantargia based on a risk-adjusted NPV using a 12.5% discount rate and including net cash at end-Q119, which results in a value of SEK2.62bn or SEK36.0/share vs SEK2.47bn or SEK37.3/share previously. The increase in total NPV is due to rolling our model forward and a higher net cash position following the share issue, with the lower per-share value resulting from an increased number of shares. We make no other changes to the assumptions described in detail in our initiation report. Following the Q119 results we make no changes to our FY19 estimates other than adjusting for the estimated net SEK100.7m cash received from the share issue.

In our initiation report we developed a model that reflects the broad potential of CAN04, given there was little information on the patient populations to be targeted. We currently assume relatively large groups of relapsed/resistant NSCLC and pancreatic cancer patients who express IL1RAP. With the new data in hand, Cantargia has been reviewing its plans for late-stage CAN04 development. Based on the updates to the CANFOUR study clinicaltrials.gov entry, and after speaking with management, it seems that the initial patient populations being targeted could be smaller than we currently model. This is fairly typical in novel drug R&D, where companies focus on an ideal subset of patients with the idea that once the drug is on the market, its label can be expanded to other patient groups. For example, large pharma Novartis, with no lack of resources, has initiated three Phase III trials across the full spectrum of patients in NSCLC after the canakinumab Phase III data unexpectedly showed potential in this indication (discussed in our initiation note).

Although, we currently use a larger patient population, we are conservative with the market penetration rate (10%) to reflect the uncertainty about the CAN04 positioning. In general, assumptions such as addressable patient population, market penetration and the pricing of the drug typically would interplay, ie smaller patient population could allow estimating higher market penetration and higher pricing. For now we make no changes to our approach, but we will revisit these assumptions when the company provides further information post their discussions with the FDA and EMA.

Exhibit 2: Sum-of-the-parts Cantargia valuation

Product

Launch

Peak sales
($m)

Unrisked NPV (SEKm)

Unrisked NPV/
share (SEK)

Technology probability (%)

rNPV
(SEKm)

rNPV/share (SEK)

CAN04 - NSCLC

2026

3,091

6,125.0

84.1

15%

994.5

13.7

CAN04 - pancreatic cancer

2024

2,100

6,125.5

85.4

15%

1,378.6

18.9

Net cash at end-Q119

251.2

3.4

100%

251.2

3.4

Valuation

12,591.7

173.0

 

2,624.3

36.0

Source: Edison Investment Research. Note: WACC = 12.5% for product valuations.

Exhibit 3: Financial summary

SEK'000s

2017

2018

2019e

2020e

December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

Research and development

(52,419)

(76,951)

(86,951)

(109,602)

EBITDA

 

 

(60,010)

(93,306)

(94,924)

(117,815)

Operating Profit (before amort. and except.)

 

 

(60,010)

(93,306)

(94,924)

(117,815)

Intangible Amortisation

0

0

0

0

Exceptionals

0

0

0

0

Other

0

0

0

0

Operating Profit

(60,010)

(93,306)

(94,924)

(117,815)

Net Interest

(243)

2,145

360

0

Profit Before Tax (norm)

 

 

(60,253)

(91,161)

(94,565)

(117,815)

Profit Before Tax (reported)

 

 

(60,253)

(91,161)

(94,565)

(117,815)

Tax

0

0

0

0

Profit After Tax (norm)

(60,253)

(91,161)

(94,565)

(117,815)

Profit After Tax (reported)

(60,253)

(91,161)

(94,565)

(117,815)

Average Number of Shares Outstanding (m)

32.4

66.2

69.5

72.8

EPS - normalised fully diluted (SEK)

 

 

(1.86)

(1.38)

(1.36)

(1.62)

Dividend per share (SEK)

0.0

0.0

0.0

0.0

Gross Margin (%)

N/A

N/A

N/A

N/A

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

 

 

2,957

2,957

2,957

2,957

Intangible Assets

0

0

0

0

Tangible Assets

0

0

0

0

Investments

2,957

2,957

2,957

2,957

Current Assets

 

 

271,496

168,486

174,623

56,808

Stocks

0

0

0

0

Debtors

0

0

0

0

Cash

149,781

76,528

172,984

55,169

Other*

121,715

91,958

1,639

1,639

Current Liabilities

 

 

(28,334)

(16,398)

(16,398)

(16,398)

Creditors

(28,334)

(16,398)

(16,398)

(16,398)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

0

0

0

0

Long term borrowings

0

0

0

0

Other long term liabilities

0

0

0

0

Net Assets

 

 

246,119

155,045

161,182

43,367

CASH FLOW

Operating Cash Flow

 

 

(40,860)

(105,165)

(94,924)

(117,815)

Net Interest

(243)

478

360

0

Tax

0

0

0

0

Capex

0

0

0

0

Acquisitions/disposals

0

0

0

0

Financing

304,479

0

100,700

0

Other

(139,499)

31,434

90,320

0

Dividends

0

0

0

0

Net Cash Flow

123,877

(73,253)

96,456

(117,815)

Opening net debt/(cash)

 

 

(25,904)

(149,781)

(76,528)

(172,984)

HP finance leases initiated

0

0

0

0

Other

0

0

0

0

Closing net debt/(cash)

 

 

(149,781)

(76,528)

(172,984)

(55,169)

Source: Cantargia accounts, Edison Investment Research. Note: *Mainly short-term investments.


General disclaimer and copyright

This report has been commissioned by Cantargia and prepared and issued by Edison, in consideration of a fee payable by Cantargia. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

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Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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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New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

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The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

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London +44 (0)20 3077 5700

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Cantargia and prepared and issued by Edison, in consideration of a fee payable by Cantargia. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: 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 and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. 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.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, 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 securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. 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, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “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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Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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. 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 (i.e. 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.

United Kingdom

This document is prepared and provided by Edison 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.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison 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. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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