Mendus — Plans falling into place for vididencel pivotal study

Mendus (OMX: IMMU)

Last close As at 05/05/2025

SEK6.09

0.80 (15.12%)

Market capitalisation

SEK267m

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Research: Healthcare

Mendus — Plans falling into place for vididencel pivotal study

Mendus’s Q125 report included no surprises, with the company staying on track to secure large-scale GMP production of vididencel and Phase III readiness by H225, which we see as the most significant upcoming catalysts for the company. Key highlights for the quarter were regulatory endorsements from both the FDA and EMA on the upcoming registrational study for vididencel, as well as first patient enrolment in the Phase II, investigator-sponsored CADENCE study, data from which will contribute to the safety dossier for vididencel, ahead of the Phase III trial. The Q125 operating loss was SEK30.2m, down 14.4% y-o-y, albeit fully attributable to lower R&D costs related to the technology transfer to manufacturing partner NorthX Biologics. Note that this will reverse in the next few quarters and should not affect our FY25 projections or estimates for the cash runway (into early 2026, in line with management guidance). We expect no material change to our valuation from the Q125 results.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Healthcare

Q125 results

6 May 2025

Price SEK6.09
Market cap SEK266m

Net cash at 31 March 2025 (excluding lease liabilities)

SEK83.9m

Shares in issue

50.4m
Free float 25.0%
Code IMMU
Primary exchange OMX
Secondary exchange N/A
Price Performance

Business description

Mendus is a clinical-stage immunoncology (IO) company based in Sweden and the Netherlands. The company specialises in allogeneic dendritic cell biology and currently has two lead, cell-based, off-the-shelf therapies for haematological and solid tumours.

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

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

Year end Revenue (SEKm) PBT (SEKm) EPS (SEK) DPS (SEK) P/E (x) Yield (%)
12/23 29.6 (101.6) (4.39) 0.00 N/A N/A
12/24 5.0 (128.4) (2.64) 0.00 N/A N/A
12/25e 0.0 (125.6) (2.49) 0.00 N/A N/A
12/26e 864.7 777.4 15.44 0.00 0.4 N/A

The key takeaway, in our view, from the Q1 results is the steady progress towards Phase III readiness for lead asset vididencel, expected by H225, in line with previously communicated timelines. Putting good manufacturing practice (GMP) production in place to support the upcoming pivotal trial and meet subsequent commercial demands has been a strategic priority for Mendus. We believe this is a key differentiator, in light of the manufacturing challenges related to cell therapies, and is supportive of vididencel’s position as an off-the-shelf maintenance treatment for acute myeloid leukaemia.

Other major highlights for the period were the regulatory thumbs-up from the FDA and EMA on the Phase III trial design and strategy, as well as first patient enrolment in the Phase II CADENCE study, sponsored by the Australasian Leukaemia and Lymphoma Group. These, along with the manufacturing capabilities progressing as planned, will likely strengthen the company’s position in its subsequent dialogue with potential licensing partners. Current gross cash at hand (SEK84.7m at end-Q125) should provide headroom to this milestone (into 2026, according to our projections and management guidance).

Operationally, the period threw up no surprises, save the lower R&D expenses (SEK21.7m vs SEK29.0m in Q124), which were attributed to the lower technology transfer costs to NorthX Biologics recognised during the quarter. We expect this to reverse over the next few quarters, given the SEK20.6m pre-paid expenses related to the transfer recognised in the balance sheet at the end of the period, which we believe will be fully expensed within FY25. Overall, we do not expect this to affect our operating estimates for FY25. We will update our estimates based on the Q125 results but do not expect material changes to our valuation.

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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.

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