Mendus — Regulatory endorsement supports vididencel focus

Mendus (OMX: IMMU)

Last close As at 04/01/2025

SEK8.40

0.60 (7.69%)

Market capitalisation

SEK424m

More on this equity

Research: Healthcare

Mendus — Regulatory endorsement supports vididencel focus

Mendus’s lead asset, vididencel, is fast approaching the pivotal stages of development in acute myeloid leukaemia (AML), with recent endorsements from both the FDA and EMA (on the design of the planned registrational trial). Separately, Mendus has decided to cease further development for its second asset, ilixadencel, after the termination of its collaboration agreement with Institut Bergonié, sponsor of the REGOMUNE trial. We note that the termination was due to this basket study being prematurely halted, and not specifically related to ilixadencel. We view Mendus’s new streamlined approach to its lead programme as logical, especially given the promising long-term survival data from the ADVANCE II trial. For ilixadencel, management plans to explore other strategic options, of which a partnering agreement may be a priority, in our view. As we adjust our estimates to reflect the new approach for ilixadencel’s development plan, our valuation shifts slightly to SEK39.0/share (SEK40.3/share previously).

Jyoti Prakash

Written by

Jyoti Prakash

Analyst, Healthcare

Mendus_resized

Healthcare

Mendus

Regulatory endorsement supports vididencel focus

Valuation update

Pharma and biotech

3 January 2025

Price

SEK8.4

Market cap

SEK423m

SEK11.1/US$

Net cash (SEKm) at 30 September 2024 (excluding lease liabilities)

108.5

Shares in issue

50.4m

Free float

25%

Code

IMMU

Primary exchange

Nasdaq Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(5.5)

5.1

(18.9)

Rel (local)

(4.5)

10.0

(24..6)

52-week high/low

SEK10.72

SEK7.47

Business description

Mendus is a clinical-stage immuno-oncology company based in Sweden and the Netherlands. It specialises in allogeneic dendritic cell biology and currently has two lead cell-based, off-the-shelf therapies for haematological and solid tumours.

Next events

CADENCE interim update (AML)

H225

Vididencel pivotal-stage ready (AML)

H225

Analysts

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Arron Aatkar, PhD

+44 (0)20 3077 5700

Mendus is a research client of Edison Investment Research Limited

Mendus’s lead asset, vididencel, is fast approaching the pivotal stages of development in acute myeloid leukaemia (AML), with recent endorsements from both the FDA and EMA (on the design of the planned registrational trial). Separately, Mendus has decided to cease further development for its second asset, ilixadencel, after the termination of its collaboration agreement with Institut Bergonié, sponsor of the REGOMUNE trial. We note that the termination was due to this basket study being prematurely halted, and not specifically related to ilixadencel. We view Mendus’s new streamlined approach to its lead programme as logical, especially given the promising long-term survival data from the ADVANCE II trial. For ilixadencel, management plans to explore other strategic options, of which a partnering agreement may be a priority, in our view. As we adjust our estimates to reflect the new approach for ilixadencel’s development plan, our valuation shifts slightly to SEK39.0/share (SEK40.3/share previously).

Year
end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/22

3.4

(138.8)

(13.9)

0.0

N/A

N/A

12/23

29.6

(101.6)

(4.4)

0.0

N/A

N/A

12/24e

5.2

(135.8)

(2.8)

0.0

N/A

N/A

12/25e

0.0

(122.1)

(2.4)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS adjusted for 20:1 share consolidation (June 2024).

Regulatory green light for vididencel Phase III trial

Mendus started 2025 on an encouraging note, with positive feedback following the end-of-Phase 2 meeting with the FDA and the EMA on its trial design (including patient population, control arm and primary and secondary endpoints) and strategy for the planned pivotal trial. The Phase III programme will evaluate vididencel in combination with oral azacitidine as a maintenance treatment in AML. Following the updated long-term survival data from ADVANCE II, as well as confirmation that the large-scale manufacturing of vididencel through the alliance with NorthX Biologics is on track, this feedback is another endorsement of vididencel’s potential in AML, in our view, and we believe it supports Mendus’s decision to focus exclusively on its lead programme. For a more detailed discussion, please see our recent outlook note.

Ilixadencel on hold – strategy adjustment

Given that Mendus’s core focus is vididencel in AML, ilixadencel was being explored more opportunistically in the earlier stages of clinical development. Therefore, we are not surprised by the company’s decision to cease further development following the news that Institut Bergonié, sponsor of REGOMUNE, has halted its collaboration. Ilixadencel has previously shown encouraging data in solid tumours, and we believe the programme now represents an opportunity for Mendus to seek partnerships to support further development efforts.

Valuation: SEK1.96bn or SEK39.0 per share

We still see potential in ilixadencel, but tweak our estimates to reflect higher risk. Our valuation adjusts to SEK1.96bn or SEK39.0/share (SEK2.03bn or SEK40.3/share previously); ilixadencel now accounts for 9% of our valuation (16.6% previously).

Valuation: Adjusts to SEK1.96bn or SEK39.0 per share

We have made certain adjustments to our assumptions and estimates for the ilixadencel programme, reflecting the company’s decision to halt further internal development activities for the candidate (detailed below).

Ilixadencel is an intratumoural immune primer comprising pro-inflammatory activated allogeneic dendritic cells (DCs), which, when injected into a tumour, cause local recruitment and activation of the patient’s immature DCs, natural killer (NK) cells and T-cells, driving anti-cancer responses. The candidate has previously been tested in combination with tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) in solid tumours. While data from these studies were informative, given the successes of ICIs in these indications, management made the strategic decision to pivot towards indications where ICIs are considered less effective.

In line with this pivot, Mendus signed a collaborative agreement with Institut Bergonié in July 2024, to test ilixadencel in soft tissue sarcomas (STS) as part of an ongoing Phase I/II basket trial (REGOMUNE). The trial was a multi-centre, prospective open-label study assessing the combination of regorafenib (a TKI) and avelumab (an ICI) in various solid tumours. Ilixadencel was set to be evaluated as part of a combination regimen in one of the treatment arms in up to 43 STS patients. Mendus’s contribution to the trial was limited to supplying ilixadencel for the STS cohort (regorafenib and avelumab were supplied by Bayer and Merck, respectively). Management had previously communicated that preparatory activities for the trial would be completed in Q424. However, the collaboration has since been terminated, which we believe stems from Bayer’s decision to no longer supply regorafenib.

Given the advanced stages of development for lead asset vididencel, management has decided to cease further internal development work on ilixadencel, and will pursue other strategic options instead. We believe a licensing deal would be the preferred option.

Given these developments, we have made the following adjustments to our assumptions for the ilixadencel programme in our model:

We assume there will be no further development work on the asset and a licensing partnership will be signed in 2026, with the partner taking responsibility for Phase II development and beyond. We had previously assumed Mendus would complete Phase II development in-house and license thereafter in 2028.

We continue to assume that the target indication will be STS, but now expect a market launch in 2033 (2032 previously), with peak sales (US$400m) achieved in 2038. We reduce the probability of success for the programme to 7.5% (10% previously).

We also reduce our estimate of the deal value to US$250m (US$350m previously), with an upfront payment of US$20m (US$50m previously).

We continue to use a tiered royalty rate, but adjust this to 9–12% (12–15% previously) given the earlier stage of clinical development at the assumed time of signing a partner.

Following these adjustments, our risk-adjusted net present value (rNPV) for ilixadencel is now SEK178m or SEK3.5/share (SEK336m or SEK6.7/share previously). With all of our other assumptions remaining unchanged, our overall valuation for Mendus shifts to SEK1.96bn or SEK39.0/share (from SEK2.0bn or SEK40.3/share previously), with ilixadencel now accounting for 9% of the overall valuation (from 16.6% previously). If we were to assume no contribution from ilixadencel, the valuation would reset at SEK1.78bn or SEK35.4/share. A breakdown of our updated rNPV is provided in Exhibit 1.

Exhibit 1: Mendus rNPV valuation

Product

Indication

Launch

Peak sales
($m)

NPV
(SEKm)

Probability of success

rNPV
(SEKm)

NPV/share
(SEK/share)

Vididencel (DCP-001)

AML

2029

930

3,271

30.0%

1,224

24.30

Vididencel (DCP-001)

Ovarian cancer

2031

720

1,903

15.0%

451

8.96

Ilixadencel

STS

2033

400

898

7.5%

178

3.54

Net cash at 30 September 2024

108.5

100.0%

108.5

2.15

Valuation

 

 

 

6,181

1,962

38.95

Source: Edison Investment Research

Exhibit 2: Financial summary

Accounts: IFRS, Yr end: December; SEK’000s

2022

2023

2024e

2025e

Income statement

 

 

 

 

Total revenue

3,375

29,612

5,150

0

Cost of sales

0

0

0

0

Gross profit

3,375

29,612

5,150

0

SG&A (expenses)

(44,028)

(30,748)

(27,673)

(28,503)

R&D costs

(87,049)

(92,653)

(105,182)

(87,027)

Other income/(expense)

(1,134)

(559)

(500)

0

Exceptionals and adjustments

0

0

0

0

Reported EBITDA

(128,836)

(94,348)

(128,204)

(115,531)

Depreciation and amortisation

(4,848)

(6,303)

(6,486)

(6,462)

Reported Operating Profit/(loss)

(133,684)

(100,651)

(134,690)

(121,992)

Finance income/(expense)

(5,101)

(968)

(1,140)

(84)

Other income/(expense)

 

 

 

 

Exceptionals and adjustments

0

0

0

0

Reported PBT

(138,785)

(101,619)

(135,830)

(122,077)

Adjusted PBT

(138,785)

(101,619)

(135,830)

(122,077)

Income tax expense

0

0

0

0

Reported net income

(138,785)

(101,619)

(135,830)

(122,077)

 

 

 

 

 

Basic average number of shares, m

10.0

23.1

48.6

50.4

Basic EPS (SEK)

(13.92)

(4.39)

(2.80)

(2.42)

Diluted EPS (SEK)

(13.92)

(4.39)

(2.80)

(2.42)

 

 

 

 

 

Balance sheet

 

 

 

 

Property, plant and equipment

13,899

11,197

8,760

6,087

Intangible assets

532,441

532,441

532,441

532,441

Right of use assets

26,216

23,247

20,657

18,355

Other non-current assets

618

624

624

624

Total non-current assets

573,174

567,509

562,482

557,508

Cash and equivalents

41,851

120,782

86,379

49,276

Prepaid expenses and accrued income

1,919

64,359

32,451

2,451

Other current assets

3,442

3,302

3,302

3,302

Total current assets

47,212

188,443

122,132

55,029

Non-current loans and borrowings

22,845

850

850

50,850

Non-current lease liabilities

23,706

21,115

21,115

21,115

Total non-current liabilities

46,551

21,965

21,965

71,965

Trade and other payables

7,411

8,129

8,129

8,129

Current loans and borrowings

29,198

0

0

0

Short-term lease liabilities

2,413

2,523

2,523

2,523

Other current liabilities

20,376

18,609

18,609

18,609

Total current liabilities

59,398

29,261

29,261

29,261

Equity attributable to company

514,437

704,726

633,387

511,311

 

 

 

 

 

Cash flow statement

 

 

 

 

Operating Profit/(loss)

(133,684)

(100,651)

(134,690)

(121,992)

Depreciation and amortisation

4,848

6,303

6,486

6,462

Other adjustments

(6,390)

(1,966)

0

0

Movements in working capital

27,030

(65,479)

31,908

30,000

Interest paid / received

(1,135)

(968)

(1,140)

(84)

Income taxes paid

0

0

0

0

Cash from operations (CFO)

(109,331)

(162,761)

(97,436)

(85,615)

Capex

(12,324)

(1,823)

(1,458)

(1,488)

Acquisitions & disposals net

0

0

0

0

Other investing activities

0

1,380

0

0

Cash used in investing activities (CFIA)

(12,324)

(443)

(1,458)

(1,488)

Net proceeds from issue of shares

0

297,904

64,491

0

Movements in debt

8,194

(55,807)

0

50,000

Other financing activities

0

0

0

0

Cash flow from financing activities

8,194

242,097

64,491

50,000

Increase/(decrease) in cash and equivalents

(113,461)

78,893

(34,403)

(37,102)

Cash and equivalents at beginning of period

155,313

41,851

120,781

86,378

Cash and equivalents at end of period

41,851

120,781

86,378

49,275

Net (debt) cash

(10,192)

119,932

85,529

(1,574)

Source: Company reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by Mendus and prepared and issued by Edison, in consideration of a fee payable by Mendus. Edison Investment Research standard fees are £60,000 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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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

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United Kingdom

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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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20 Red Lion Street

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London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Mendus and prepared and issued by Edison, in consideration of a fee payable by Mendus. Edison Investment Research standard fees are £60,000 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 2025 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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