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Potentially transformational merger

Immunicum 16 December 2020 Update
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Immunicum

Potentially transformational merger

Company update

Pharma & biotech

16 December 2020

Price

SEK7.92

Market cap

SEK731m

Last reported net cash (SEKm) at Q320

197.6

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

(5.0)

(25.4)

(24.1)

Rel (local)

(6.6)

(29.3)

(33.1)

52-week high/low

SEK12.12

SEK6.61

Business description

Immunicum is a clinical-stage immunoncology 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

EGM

18 December 2020

Multi-indication Phase Ib (ILIAD) next safety data

H121

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

On 18 November, Immunicum announced that it had agreed to acquire biotech company DCprime by issuing 73.9k new shares or 44% of the enlarged capital. Based in the Netherlands, the privately owned biotech is developing a novel class of allogeneic dendritic cell-based cancer vaccines. The most advanced programme is in AML (Phase II) with interim data presented at the ASH conference on 5–8 December. Immunicum held an Investor event on 8 December, while the EGM will be held on 18 December. Our valuation and estimates are under review and we will revise our model once the merger is complete.

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

N/A

N/A

N/A

N/A

N/A

N/A

12/21e

N/A

N/A

N/A

N/A

N/A

N/A

Note: *PBT and EPS are reported.

Complementary assets and business synergies

With both ilixadencel and DCP-001 now under the same roof, Immunicum has two allogeneic dendritic cell-based cancer vaccinations for intradermal and intratumoural administrations and can target both solid tumours and haematological ‘liquid’ malignancies. The positioning is also different. Ilixadencel is being developed as an immune primer in combination with anti-cancer therapies, while DCP-001 is aimed at reducing the risk of cancer relapse after standard of care. The newly combined company will maintain its corporate headquarters in Stockholm, Sweden, with additional R&D activities in Leiden, the Netherlands.

Acquisition follows strategy update in September

Following his appointment as CEO in August, Sven Rohmann updated the company’s strategy in September. GIST and sarcoma-type cancers were highlighted as proven indications that do not require a partner to reach the market (Immunicum has Phase I data with ilixadencel) and orphan disease opportunities that could shorten ilixadencel’s path to the market. The Phase Ib/II ILIAD trial, a multi-indication study with ilixadencel in combination with checkpoint inhibitors (CPIs), is moving towards completion of Phase Ib after no dose-limiting toxicities were seen in the staggered phase. In renal cell carcinoma Immunicum will pursue ilixadencel in a triple combination with PD1 and CTLA4 CPIs.

Valuation: Under review pending merger completion

Since DCprime is a private company with limited information available, we believe it will take time for the share price to reflect the potential of DCP-001. Our valuation is under review (last published on 3 September at SEK2.27bn or SEK24.6/share) and we will evaluate DCP-001’s potential when the merged company releases its joint business and development plan during Q121. Immunicum guided that the combined entity has cash reach until 2022, while DCprime’s shareholder Van Herk Investments intends to invest up to SEK82.5m in the combined company.

Interim ADVANCE-II data in AML at ASH

Using its platform, DCprime was able to transform proprietary allogeneic leukaemia cells (DCOne line) into dendritic cell (DC) phenotype. Because these DCs are derived from leukemic progenitors, they contain multiple antigens making them highly immunogenic in combination with their inflammatory profile and dendritic cell phenotype. DCP-001 is administered intradermally.

DCprime presented Phase II ADVANCE-II data for its lead asset DCP-001 at the ASH 2020 annual conference (5–8 December). ADVANCE-II is an ongoing, open-label Phase II trial investigating DCP-001 as a potential relapse vaccination in acute myeloid leukaemia (AML) patients who are in their first complete remission but still have measurable residual disease (MRD).

For decades, AML treatment relied largely on intensive chemotherapy and allogeneic hematopoietic stem cell transplantation (HSCT), which is unsuccessful in 60–80% of patients due to the persistence of MRD (van de Loosdrecht et al, 2018). Over the last few years, several new therapies have been approved, so the treatment paradigm is likely to change. However, having reviewed the emerging treatment options (see below), we find that the survival benefit of the new therapies is limited, especially in elderly patients, so the unmet need in AML is likely to persist.

Given the high relapse rate in AML, the scope of the ADVANCE-II study is to see whether remissions can be lengthened with DCP-001. Interim results included data from the ten patients in the first, lower dose cohort. Five patients in the higher dose cohort have started, but not completed the vaccination schedule. Two patients converted to MRD negative following vaccination and five patients have remained in complete remission despite being MRD positive. Conversely, three patients relapsed prior to completing the vaccination schedule, highlighting that timing and patient status could play a critical factor. Immunogenicity data also highlight that DCP-001 induced an immune response to tumour-associated antigens (TAAs) relevant to AML. Top-line efficacy data are expected in Q421 and will include data from the second, higher dose cohort.

AML: Changing treatment paradigm, but still an unmet need

AML normally originates in the bone marrow (where new blood cells are made), but often quickly moves into the blood, resulting in uncontrolled growth and accumulation of malignant white blood cells, which fail to function normally and interfere with the production of normal blood cells. AML is the most common type of acute leukaemia in adults and affects nearly 40,000 patients in the EU and US (new cases per year). Less than one-third of all AML patients survive for five-years, while for 65+ year-olds this rate drops to 10–15%.

Until recently, the standard-of-care treatment for AML was primarily based on chemotherapy (cytarabine with anthracycline or mitoxantrone), followed by a stem cell transplant where appropriate. The goal of treatment is to reduce the blasts in the bone marrow to below 5% and return the blood cell counts to normal levels. A bone marrow transplant is generally recognised as the only curative treatment option, but is not always appropriate.

Rydapt (midostaurin, Novartis) was the first novel targeted therapy approved in April 2017 which specifically targets FLT3 for the treatment of adults with newly diagnosed FLT3-ITD AML in combination with standard-of-care chemotherapy. In the Phase III trial, overall survival was increased from approximately two years to just over six years. Consensus forecasts Rydapt sales of $240m in 2026 (source: EvaluatePharma).

In November 2018, the FDA approved gilteritinib (Xospata, Astellas) as monotherapy for adults with FLT3-positive AML in a relapsed or refractory setting. In the Phase III trial, treatment with gilteritinib resulted in complete remissions (CRs), or CRs with partial haematologic recovery in 21% of patients (95% CI 14.5%–28.8%). Consensus forecasts Xospata sales of $775m in 2026.

Outside the FLT3 targeted therapy space, Venetoclax (BCL-2 inhibitor, Venclexta, AbbVie/Roche) has generated significant interest. In November 2018, the FDA granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of 75+ year-old patients with newly diagnosed AML. Venetoclax has been demonstrated to have efficacy similar to standard-of-care chemotherapy regimens, but with a much better safety tolerability profile.

Other novel drugs that the FDA approved over the last few years include:

Glasdegib in November 2018 (a hedgehog pathway inhibitor, Daurismo, Pfizer; consensus sales forecast of $405m in 2026); and

IDH1/IDH2 inhibitors ivosidenib in July 2018 (Tibsovo, Agios Pharmaceuticals; consensus AML sales forecast of $763m in 2026) and enasidenib in August 2017 (Idhifa, BMS/Celgene; consensus AML sales forecast of $257m in 2026).

Despite these advances, novel drugs rarely extend survival by more than a few months, so survival rates remain poor and the unmet need in AML remains high. Most of these novel drugs were approved over the last three or four years, so the clinical treatment paradigm and guidelines are still in the development stage, which makes it an interesting indication to follow. The ongoing ADVANCE-II trial investigates DCP-001 as a potential relapse vaccination in AML patients who are in their first complete remission but still have MRD. EvaluatePharma calculates the total market value of AML drugs at $910m in 2020, which is forecast to grow to $10.1bn in 2026.

Additional transaction details; EGM on 18 December

Erik Manting, the current CEO of DCprime, will become chief business officer and deputy CEO of the combined company. Mr Manting, PhD, is a seasoned pharma and biotech executive with several years of research experience in immunology and 15 years’ experience in commercial and management roles in banking. We note that as the acquisition was initiated during the ongoing pandemic, it indicates a keen interest by both companies in working together and a smooth transition, in our view.

DCprime’s current majority shareholder, Van Herk Investments, will own 43% of the combined company. Van Herk Investments is a European life science investor founded in Rotterdam in 1951 (invested in Zealand Pharma, Ablynx, Crucell and Galapagos among others). Van Herk Investments and Immunicum’s largest shareholder Fourth Swedish National Pension Fund (AP4) have expressed their support for the merger. The EGM is scheduled on 18 December 2020. Closure of the transaction is expected to take place at the end of December 2020.

Immunicum indicated that the funds that would be available for the combined company should finance operations into 2022. If the merger is approved, Van Herk Investments intends to invest up to SEK82.5m in the company. Furthermore, Immunicum will ask the EGM to approve a mandate for the board of directors to issue shares up to 20% of the total outstanding amount. Cash reach including these additional funds will depend on R&D activities post-merger.

Following completion of the transaction, the immediate plan for the combined company will be the expansion into haematological malignancies and enriched clinical catalysts in the near term (Exhibit 1).

Exhibit 1: Expected clinical timelines from merged entity

Source: Company presentation

Exhibit 2: Financial summary

 

 

 

SEK'000s

2018

2019

2020e

2021e

Year end 31 December

 

 

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

 

 

 

 

 

 

Revenue

 

 

 

0

0

N/A

N/A

Operating expenses

 

 

(98,029)

(133,213)

N/A

N/A

Depreciation

 

 

 

(5)

N/A

N/A

N/A

Operating income

 

 

184

893

N/A

N/A

Reported operating profit

 

 

(97,845)

(132,325)

N/A

N/A

Net Interest

 

 

 

(15)

N/A

N/A

N/A

Profit before tax (reported)

 

 

(97,860)

(134,016)

N/A

N/A

Reported tax

 

 

 

0

N/A

N/A

N/A

Profit after tax (reported)

 

 

(97,860)

(134,016)

N/A

N/A

Minority interests

 

 

0

0

N/A

N/A

Net income (reported)

 

 

(97,860)

(134,016)

N/A

N/A

Basic average number of shares outstanding

 

51,387

51,387

N/A

N/A

EPS - basic reported (SEK)

 

 

(1.90)

(1.49)

N/A

N/A

BALANCE SHEET

 

 

 

N/A

N/A

N/A

Non-current Assets

 

 

10

N/A

N/A

N/A

Property Plant and equipment, net

 

9

9

N/A

N/A

Other financial assets

 

 

1

N/A

N/A

N/A

Other non-current Assets

 

 

0

N/A

N/A

N/A

Current Assets

 

 

450,362

N/A

N/A

N/A

Cash and cash equivalents

 

 

443,798

296,811

N/A

N/A

Accounts receivable

 

 

3,307

2,983

N/A

N/A

Marketable securities and short-term investments

0

0

N/A

N/A

Prepaid expenses

 

 

3,257

3,783

N/A

N/A

Current Liabilities

 

 

43,482

30,199

N/A

N/A

Accounts payable

 

 

31,266

12,819

N/A

N/A

Accrued other liabilities

 

 

11,378

15,736

N/A

N/A

Other current liabilities

 

 

838

1,644

N/A

N/A

Non-current Liabilities

 

 

850

850

N/A

N/A

Long term debt

 

 

850

850

N/A

N/A

Equity

 

 

 

406,041

N/A

N/A

N/A

CASH FLOW

 

 

 

 

 

N/A

N/A

N/A

Cash Flow from Operations

 

 

 

 

 

N/A

N/A

EBIT (Operating profit)

 

 

(97,845)

(132,325)

N/A

N/A

Depreciation

 

 

 

58

N/A

N/A

N/A

Income Tax paid

 

 

0

0

N/A

N/A

Other Working Capital changes

 

(6,867)

(13,485)

N/A

N/A

Cash interest paid

 

 

(14)

N/A

N/A

N/A

Cash interest received

 

 

0

N/A

N/A

N/A

Net cash used in Operating activities

 

(104,668)

(145,808)

N/A

N/A

Cash Flow from Investing

 

 

 

N/A

N/A

N/A

Purchase of fixed assets

 

 

0

N/A

N/A

N/A

Sale of Investments

 

 

N/A

N/A

N/A

Net cash used in investing activities

 

0

(251)

N/A

N/A

Cash Flow from Financing

 

 

 

 

N/A

N/A

Change in Capital Stock

 

 

419,584

756

N/A

N/A

Net cash from Financing activities

 

419,584

756

N/A

N/A

Net Changes in Cash and Cash Equivalent

 

314,916

(145,303)

N/A

N/A

Cash and Cash Equivalents - Beginning

 

128,883

443,799

N/A

N/A

Cash and Cash Equivalents - End

 

443,799

296,812

N/A

N/A

Net cash/(debt)

442,948

295,961

N/A

N/A

Source: Immunicum accounts, Edison Investment Research


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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.

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Copyright: Copyright 2020 Edison Investment Research Limited (Edison).

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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 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.

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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

1185 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 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

1185 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

1185 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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