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FDA grants RMAT designation

Immunicum 15 May 2020 Update
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Immunicum

FDA grants RMAT designation

R&D update

Pharma & biotech

15 May 2020

Price

SEK9.55

Market cap

SEK882m

Last reported net cash (SEKm) at Q120

263.4

Shares in issue

92.3m

Free float

92%

Code

IMMU

Primary exchange

Nasdaq Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

16.4

(5.1)

21.3

Rel (local)

19.8

20.7

27.0

52-week high/low

SEK16.14

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

Q220

RCC Phase II (MERECA) next update

Mid 2020

Analyst

Jonas Peciulis

+44 (0)20 3077 5728

Immunicum is a research client of Edison Investment Research Limited

Like many biotechnology companies, Immunicum’s share price has undergone a period of volatility, but has now rebounded to its pre-COVID-19 level. To a large extent, this rebound was due to a regenerative medicine advanced therapy (RMAT) designation received from the FDA. It provides the same benefits as a breakthrough therapy designation, so could shorten the development timelines of ilixadencel, Immunicum’s allogeneic off-the-shelf dendritic cell immune primer. Although the ongoing COVID-19 pandemic has introduced some uncertainty about timelines, Immunicum should report interesting updates later this year from its both key trials with ilixadencel, Phase II MERECA and Phase Ib/II ILIAD. Our valuation is little changed at SEK2.30bn or SEK24.9 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.

RMAT designation received

On 6 May 2020, Immunicum announced it had received a RMAT designation from the FDA for its lead therapy, ilixadencel, for the treatment of metastatic renal cell carcinoma (RCC). 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 means that ilixadencel development timelines could be shorter, which is the key advantage of this designation.

More news to come from MERECA and ILIAD trials

The most significant recent development and a positive surprise was the 24-month follow-up update from the completed Phase II MERECA trial with ilixadencel in RCC in February 2020. The next check is at 30-month follow-up and should be available mid-2020. The key ongoing Phase Ib/II trial, ILIAD (ILIxadencel in combination CPIs in patients with ADvanced cancer), is close to completing the staggered phase. If the safety profile is confirmed, the rate of patient recruitment in the trial could increase as early as in Q320 (depending on COVID-19 developments).

Valuation: SEK2.30bn or SEK24.9 per share

Our valuation of Immunicum is marginally lower at SEK2.30bn or SEK24.9 per share after updating the last reported cash position. With regards to RMAT designation, 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 is well capitalised for a biotech company with cash of SEK263m at the end of Q120. This in particular will be helpful to weather the COVID-19 storm.

Frequent interactions with FDA and potential surrogate endpoints could translate into faster development

A major advantage of an accelerated development (included in the RMAT designation) is the possibility of using surrogate endpoints. Clinical efficacy trials in RCC can be long if overall survival is the primary endpoint. Using surrogate endpoints, such as durable response, progression-free survival or tumour response, could significantly shorten the time to market. As a next step, Immunicum plans to meet with the FDA and EMA (end-Q220) to discuss the development strategy for ilixadencel in RCC, so no details about the potential further trial design are available yet. We believe partnering discussions will be helped when Immunicum has some clarity on this.

RMAT is a relatively new designation, established in 2017 under the 21st Century Cures Act in the United States. It is meant to expedite the development of regenerative medicine therapies intended to address an unmet medical need. According to requirements, a drug is eligible for RMAT designation if:

it can be defined as a regenerative medicine therapy (such as cell or gene therapy);

it is intended to treat a serious condition; and

preliminary clinical evidence indicates the investigational therapy has the potential to do so.

There are a number of different designations the regulatory authorities can grant to drug developers that have different purposes and the likelihood of receiving the designation differs significantly. For example, the main requirement for orphan drug designation is that the target condition must be rare, in which case the investigational drug would likely be granted the designation. RMAT stands out because more evidence is needed. For example, preliminary clinical efficacy evidence is one of the RMAT requirements. We note that the designation comes after Immunicum presented detailed analysis of the Phase II MERECA trial results and although this cannot be interpreted as a positive review of the MERECA data by the FDA, it satisfied the required hurdle of evidence. According to the FDA own data:

in 2017, the agency received 31 requests for RMAT, of which only 35% were granted;

in 2018, 47 requests were submitted, of which 38% were granted; and

in 2019, 37 requests were submitted, of which 43% were granted.

ILIAD and MERECA trial updates; potential COVID-19 impact

MERECA trial: Next check (30-month follow-up) in mid-2020

Immunicum’s updated results from the Phase II MERECA trial with ilixadencel were a positive surprise. The data were presented at the ASCO-SITC Clinical Immuno-Oncology Symposium in February 2020, which we described in detail in our last report. The maturing data (24-month follow-up) confirmed the separation of the Kaplan-Meier curves, which was projected in September 2019 at the time of the release of the final MERECA results (18-month follow-up). In addition, Immunicum found that a stricter definition of tumour response, the confirmed objective response rate (vs best objective response rate), showed a clear difference between the active and control arms. The next check is at 30-month follow-up and should be available mid-2020.

ILIAD trial summary: Key ongoing trial

Following the completion of the MERECA trial, the main R&D focus is on the ongoing Phase Ib/II study, ILIAD. We described the trial design and the rationale in our previous report. ILIAD is expected to recruit a total of 150 patients in three solid tumour indications: gastric adenocarcinoma (GA) in combination with CPIs, non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).

The Phase Ib part of the study is ongoing, where the patients receive ilixadencel combined with Keytruda. This part is expected to enrol a total of 21 patients (Exhibit 1). The first six patients needed to be enrolled in a staggered format, which in addition to treatment includes a six-week safety period between each patient. This means it will typically take around two-and-a-half to three months between the enrolment of each patient (treatment, safety period, safety committee review). Although this design is relatively slow, it is required when a new combination of two drugs is being tested. If no safety concerns emerge, the rest of the Phase Ib trial will recruit faster. The goal of the Phase Ib part is to assess safety and define optimal dosing in combination with Keytruda.

Exhibit 1: Overall survival and immune response to Tedopi epitopes

Source: Immunicum

On 1 October 2019, Immunicum announced that the first three patients were dosed and no serious adverse events were reported. The second (and the last) cohort of three patients are being treated. This will complete the staggered phase. With its Q120 report Immunicum mentioned that, presuming no new safety issues will appear, the trial could move to the non-staggered phase by the end of Q220 (depending on COVID-19 developments), when more clinical trial sites were planned to be opened so the patients can be recruited faster. All trial sites are in the US so the ongoing COVID-19 pandemic may have some effect on timelines, but it is difficult to predict with certainty at the moment.

The ILIAD trial is important because it will be the first study to test ilixadencel in combination with CPIs. Full safety and efficacy data from the Phase Ib of ILIAD should be released in 2020 or 2021, depending on the COVID-19 impact. The Phase II part of the trial will group patients by indication (HNSCC, NSCLC and GA) into three parallel studies. The controlled efficacy data from the Phase II of ILIAD should be available in 2022.

Valuation and financials

Our valuation of Immunicum is marginally lower at SEK2.30bn or SEK24.9 per share after updating the last reported cash position. With regards to the RMAT designation, 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. 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.

Immunicum’s Q120 operating loss of SEK33.9m vs SEK29.1m a year ago indicates a similar level of spending and is in line with our expectations. As usual, R&D costs accounted for the majority of the expense and were SEK23.5m (vs SEK23.2m reported in Q119). We keep our estimates largely unchanged. Immunicum had cash of SEK263m at the end of Q120. 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 even if it causes trial delays, it is likely certain CRO costs could also be delayed, which would act as a mitigating factor.

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

Product

Launch

Peak sales
($m)

Probability

rNPV
(SEKm)

rNPV/share
(SEK)

Ilixadencel – RCC

2026

1730

25.0%

657.9

7.1

Ilixadencel – HCC

2029

880

20.0%

242.6

2.6

Ilixadencel – NSCLC

2027

1370

20.0%

643.8

7.0

Ilixadencel – HNSCC

2028

1900

20.0%

378.4

4.1

Ilixadencel – gastric adenocarcinoma

2028

1480

20.0%

295.1

3.2

Unallocated costs

100%

(184.0)

(2.0)

Net cash, last reported

100%

263.4

2.9

Valuation

2,297.3

24.9

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 3: 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

419,584

756

0

Net Changes in Cash and Cash Equivalent

 

314,916

314,916

(145,303)

(120,867)

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’s account, 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.

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

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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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1,185 Avenue of the Americas

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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).

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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.

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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