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New CEO and data update from MERECA

Immunicum 3 September 2020 Update
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Immunicum

New CEO and data update from MERECA

Company update

Pharma & biotech

3 September 2020

Price

SEK9.8

Market cap

SEK905m

Last reported net cash (SEKm) at Q220

232.2

Shares in issue

92.3m

Free float

90%

Code

IMMU

Primary exchange

Nasdaq Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(1.3)

(1.1)

34.4

Rel (local)

(3.6)

(9.2)

15.4

52-week high/low

SEK12.1

SEK5.72

Business description

Immunicum is a clinical-stage immuno-oncology company based in Stockholm, Sweden. It is developing an allogeneic off-the-shelf dendritic cell immune activator or immune primer, ilixadencel, for use in combination with checkpoint inhibitors and other anti-cancer therapies in potentially any solid tumour indications accessible via direct injection.

Next events

Multi-indication Phase Ib (ILIAD) next safety data

End-2020

RCC Phase II (MERECA) next update

Q121

Analyst

Jonas Peciulis

+44 (0)20 3077 5728

Immunicum is a research client of Edison Investment Research Limited

Last Friday, Immunicum announced that Sven Rohmann was appointed as CEO with immediate effect. Immunicum has been searching for a new management leader for a while now, with current CSO and co-founder Alex Karlsson-Parra acting as interim CEO. Dr Rohmann brings 30 years of experience as a senior executive at biotech and large pharma companies and has an extensive track record of transactions and fund-raising experience. So, the right CEO at the right time for Immunicum, in our view. These developments follow R&D updates over the summer. The latest follow-up update from the Phase II MERECA trial showed that median OS was reached in the control arm, but not yet in the ilixadencel arm, while the Phase Ib/II ILIAD trial is moving into the non-staggered phase. Our valuation is little changed at SEK2.27bn or SEK24.6 per share.

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/18

0.0

(97.9)

(1.90)

0.0

N/A

N/A

12/19

0.0

(134.0)

(1.49)

0.0

N/A

N/A

12/20e

0.0

(120.9)

(1.31)

0.0

N/A

N/A

12/21e

0.0

(122.5)

(1.33)

0.0

N/A

N/A

Note: *PBT and EPS are reported.

New CEO appointed with immediate effect

Dr Rohmann holds MD, PhD and MBA degrees and is a very experienced executive with 30 years of experience at biotechnology and large pharma companies including a 10-year career at Merck where he worked on the launch of blockbuster Erbitux. Most recently Dr Rohmann was acting CEO of another listed Swedish biotech, Oasmia Pharmaceutical, which has a commercial stage oncology product with a total out-licensing deal value of $678m. During Dr Rohmann’s leadership (2019), Oasmia raised SEK400m. Before that, he was the founding CEO of Ganymed Pharmaceuticals and led the R&D from discovery to Phase II stage. Eventually Ganymed was acquired by Astellas for €422m upfront and €860m in contingent payments. We believe the new CEO has a very relevant skill set for Immunicum, as the company has reached mid-stage and is considering late-stage R&D plans with ilixadencel.

Phase II MERECA and Phase Ib/II ILIAD trial updates

According to the latest (July) follow-up update from the MERECA trial (ilixadencel in renal cell carcinoma; RCC), the mOS was reached at 25.3 months in the sunitinib (control) group, while in the ilixadencel plus sunitinib group the mOS has not been reached yet. In the ilixadencel group, 43% of patients were still alive, vs 33% in the control group. The Kaplan-Meier curves continue to project separation. In another update, Immunicum said that the ILIAD trial is moving into the non-staggered phase after no dose-limiting toxicities were seen in the staggered phase.

Valuation: SEK2.27bn or SEK24.6 per share

Our valuation of Immunicum is little changed at SEK2.27bn or SEK24.6 per share after updating the last reported cash position. As previously, our valuation is based on ilixadencel in multiple indications, with an RCC project revision due after Immunicum releases more details about the next trial.

Phase II MERECA study latest follow up

In August 2020, Immunicum published a follow-up update from its Phase II MERECA trial, which enrolled 88 patients (active arm n=58; control arm n=30) with newly diagnosed metastatic renal cell carcinoma (RCC). This is the most advanced trial in the R&D pipeline.

According to the trial design, patients in the active arm received two injections of ilixadencel (on day 1 and day 14), then all patients in both arms underwent kidney tumour surgery. The patients were allowed to recover for six weeks after the surgery before the treatment with Sutent; this gap is mandatory due to Sutent’s toxicity. In total, the patients were followed for 18 months (from the first injection of ilixadencel). Subsequently, survival follow-ups are being conducted every six months thereafter.

The first set of data, where the patients were followed for at least 18 months, were presented in September 2019 and the maturing data (at least 24-month follow up) were released in February 2020. The announcement released in August 2020 is the third update from this study with at least 30 months of follow up. Some of the patients were followed for much longer.

The primary endpoints of the study are the hard clinical endpoints of median overall survival (mOS) and overall survival (OS) after 18 months in addition to other secondary endpoints, such as objective response rate (ORR), median progression-free survival (mPFS), time-to-progression (TTP), safety and various exploratory endpoints.

In our previous report we described the last update (at least 24-month follow up), which we interpreted as a positive surprise with key primary and secondary endpoints showing promising trends (statistical analysis is not available as the study was not powered to detect efficacy). Data to establish the mOS were still not mature in both arms at that time.

Latest follow-up update from July (at least 30 months)

The mOS was reached at 25.3 months in the control group, while in the ilixadencel group the mOS has not been reached yet. The proportion of patients alive was 43% (24/56) of patients in the ilixadencel treatment group compared with 33% (10/30) of patients in the control group. The Kaplan-Meier curves continue to project separation (some of the patients were followed for much longer than 30 months).

Exhibit 1: Kaplan-Meier curves after each patient was followed for at least 30 months

Source: Immunicum

Next steps

The next 36-month follow up will be released likely in Q121. However, Immunicum is already communicating with the regulatory authorities. Its goal is to get input on the design of the subsequent clinical trial in RCC. To this end, Immunicum benefits from the regenerative medicine advanced therapy (RMAT) designation, which the company was granted in May 2020 for the treatment of metastatic RCC (more details). The advantages of this designation include all the benefits of the fast track and breakthrough therapy designations, such as guidance and frequent interactions with the FDA, increased flexibility in clinical trial design and the possibility of using surrogate endpoints for accelerated approval. Frequent interactions with the regulator and the potential inclusion of surrogate endpoints mean that ilixadencel development timelines could be shorter, which is the key advantage of this designation.

Immunicum indicated that it is continuing discussions with the regulatory authorities to determine the optimal next development steps for ilixadencel. The company has not presented any preliminary design so far, but we understand that all options are on the table (ilixadencel triple combo with checkpoint inhibitors (CPI) and tyrosine kinase inhibitors (TKI) for front-line treatment or ilixadencel with TKI for second-line treatment).

Phase Ib/II ILIAD study update: Moving to non-staggered enrolment phase

In June 2020, Immunicum announced that the sixth patient (Exhibit 2) has completed the safety period in the ongoing Phase Ib/II ILIAD combination trial with ilixadencel and checkpoint inhibitors in various solid tumours. There were no dose-limiting toxicities, which means the study can move into the non-staggered enrolment phase.

The ILIAD study is the first trial where Immunicum is combining its ilixadencel and a checkpoint inhibitor Keytruda (pembrolizumab), therefore the safety data are of interest. A total of 21 patients should be enrolled. So far, six patients have been enrolled in a staggered way with increasing doses of ilixadencel, which means the investigators had to wait six weeks between the enrolments. Since no dose-limiting toxicities were observed, the trial can move into the quicker, non-staggered phase. In total 15 patients are still to be enrolled in the Phase Ib part of the study. Immunicum guides that this can be achieved in H121, although preliminary safety data should be released by end-2020 (depending on COVID-19 pandemic developments). The results are expected in H221.

Exhibit 2: Design of Phase Ib/II ILIAD study

Source: Immunicum

Valuation and financials

Our valuation of Immunicum is only slightly changed at SEK2.27bn or SEK24.6 per share after updating the last reported cash position. As previously, our valuation is based on ilixadencel in multiple indications (described in detail in our last outlook report), which are supported by Immunicum’s ongoing R&D programme. We will review our rNPV model for ilixadencel in RCC once more details are known about the next stage of the development following the discussions with regulators and any potential partners.

Immunicum’s H120 operating loss was SEK59.0m vs SEK62.3m a year ago, slightly lower as the MERECA study ended in around mid-2019. As usual, R&D costs accounted for the majority of the expense and were SEK41.2m (vs SEK49.0m reported in H119). We keep our estimates unchanged. Immunicum had cash of SEK232m at the end of Q220. Management has previously guided that its cash runway will extend to the end of 2021, which is in line with our model. The potential impact from the ongoing COVID-19 pandemic is difficult to forecast with certainty, but the company indicated that so far operations were not affected. There is some uncertainty about enrolment timelines in the ILIAD trial now that it has moved into the non-staggered phase. This would allow quicker enrolment with more centres active, but opening new centres could be affected depending on how the pandemic develops. The Phase Ib part of the study is still expected to be fully enrolled in H121 with results in H221, so within the existing budget.

Exhibit 3: Sum-of-the-parts Immunicum valuation

Product

Launch

Peak sales
($m)

Probability

rNPV
(SEKm)

rNPV/share
(SEK)

Ilixadencel – RCC

2026

1,730

25.0%

657.9

7.1

Ilixadencel – HCC

2029

880

20.0%

242.6

2.6

Ilixadencel – NSCLC

2027

1,370

20.0%

643.8

7.0

Ilixadencel – HNSCC

2028

1,900

20.0%

378.4

4.1

Ilixadencel – gastric adenocarcinoma

2028

1,480

20.0%

295.1

3.2

Unallocated costs

100%

(184.0)

(2.0)

Net cash, last reported

100%

232.2

2.5

Valuation

2,266.0

24.6

Source: Edison Investment Research. Note: WACC = 12.5% for product valuations. RCC: renal cell carcinoma; HCC: hepatocellular cancer; NSCLC: non-small cell lung cancer; HNSCC: head and neck squamous cell carcinoma.

Exhibit 4: Financial summary

 

 

 

SEK ('000)

2018

2019

2020e

2021e

Year end 31 December

 

 

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

 

 

 

 

 

 

Revenue

 

 

 

0

0

0

0

Operating expenses

 

 

(98,029)

(133,213)

(121,850)

(123,628)

Depreciation

 

 

 

(5)

(5)

(0)

0

Operating income

 

 

184

893

982

1,081

Reported operating profit

 

 

(97,845)

(132,325)

(120,868)

(122,547)

Net Interest

 

 

 

(15)

(1,691)

(0)

14

Profit before tax (reported)

 

 

(97,860)

(134,016)

(120,868)

(122,533)

Reported tax

 

 

 

0

0

0

0

Profit after tax (reported)

 

 

(97,860)

(134,016)

(120,868)

(122,533)

Minority interests

 

 

0

0

0

0

Net income (reported)

 

 

(97,860)

(134,016)

(120,868)

(122,533)

Basic average number of shares outstanding

 

51,387

51,387

89,710

92,258

EPS - basic reported (SEK)

 

 

(1.90)

(1.49)

(1.31)

(1.33)

BALANCE SHEET

 

 

 

 

 

 

Non Current Assets

 

 

10

252

252

252

Property Plant and equipment, net

 

9

9

0

(0)

Other financial assets

 

 

1

1

1

1

Other Non Current Assets

 

 

0

251

251

251

Current Assets

 

 

450,362

303,577

182,710

60,163

Cash and cash equivalents

 

 

443,798

296,811

175,944

53,397

Accounts receivable

 

 

3,307

2,983

2,983

2,983

Marketable securities and short-term investments

0

0

0

0

Prepaid expenses

 

 

3,257

3,783

3,783

3,783

Current Liabilities

 

 

43,482

30,199

30,199

30,199

Accounts payable

 

 

31,266

12,819

12,819

12,819

Accrued other liabilities

 

 

11,378

15,736

15,736

15,736

Other current liabilities

 

 

838

1,644

1,644

1,644

Non Current Liabilities

 

 

850

850

850

850

Long term debt

 

 

850

850

850

850

Equity

 

 

 

406,041

272,780

151,912

29,379

CASH FLOW

 

 

 

 

 

 

 

 

Cash Flow from Operations

 

 

 

 

 

 

 

EBIT (Operating profit)

 

 

(97,845)

(132,325)

(120,868)

(122,547)

Depreciation

 

 

 

58

9

0

(0)

Income Tax paid

 

 

0

0

0

0

Other Working Capital changes

 

(6,867)

(13,485)

0

0

Cash interest paid

 

 

(14)

(17)

0

0

Cash interest received

 

 

0

10

0

0

Net cash used in Operating activities

 

(104,668)

(145,808)

(120,867)

(122,547)

Cash Flow from Investing

 

 

 

 

 

 

Purchase of fixed assets

 

 

0

0

0

0

Sale of Investments

 

 

(251)

0

0

Net cash used in investing activities

 

0

(251)

0

0

Cash Flow from Financing

 

 

 

 

 

 

Change in Capital Stock

 

 

419,584

756

0

0

Net cash from Financing activities

 

419,584

756

0

0

Net Changes in Cash and Cash Equivalent

 

314,916

(145,303)

(120,867)

(122,547)

Cash and Cash Equivalents - Beginning

 

128,883

443,799

296,812

173,789

Cash and Cash Equivalents - End

 

443,799

296,812

173,789

51,256

Net cash/(debt)

442,948

295,961

175,094

52,547

Source: Immunicum accounts, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Immunicum and prepared and issued by Edison, in consideration of a fee payable by Immunicum. 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 2020 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). 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.

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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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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

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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

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NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Immunicum and prepared and issued by Edison, in consideration of a fee payable by Immunicum. 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 2020 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). 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

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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