Mendus — Potential disruptor to AML maintenance setting

Mendus (OMX: IMMU)

Last close As at 24/04/2024

SEK0.49

−0.01 (−2.00%)

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SEK494m

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Research: Healthcare

Mendus — Potential disruptor to AML maintenance setting

Mendus has reported FY23 results, summarising an active period. For its lead asset, vididencel, long-term survival data from the ADVANCE II trial reinforce the drug’s potential as maintenance therapy in acute myeloid leukaemia (AML). We look forward to the launch of the Phase II CADENCE trial in Q124 to explore potential synergy with the standard of care (Onureg, oral azacitidine), which will be an important milestone. The interim results from this trial will guide plans for the pivotal stages of development. Management also shared updates on the ALISON trial (ovarian cancer) and the preparation of a Phase II trial for ilixadencel in soft tissue sarcomas (STS). Net cash was SEK119.9m at end FY23, which we estimate provides a runway through FY24. A slight adjustment in the launch of the AML trials is partially offset by the inclusion of a broader patient population (MRD+ and MRD-), rolling our model forward and FX, resulting in a valuation of SEK2.05bn or SEK2.38 per share (previously SEK2.18bn or SEK2.52 per share).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Mendus

Potential disruptor to AML maintenance setting

FY23 results

Pharma and biotech

15 February 2024

Price

SEK0.43

Market cap

SEK371m

SEK10.5/US$

Net cash (SEKm) at 31 December 2023

119.9

Shares in issue

863.1m

Free float

37%

Code

IMMU

Primary exchange

Nasdaq Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(7.1)

(1.3)

(76.3)

Rel (local)

(8.5)

(13.6)

(77.8)

52-week high/low

SEK1.93

SEK0.30

Business description

Mendus is a clinical-stage immuno-oncology 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.

Next events

Vididencel Phase II combination trial initiation (AML)

Q124

Ilixadencel Phase II trial initiation (STS)

H124

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Mendus is a research client of Edison Investment Research Limited

Mendus has reported FY23 results, summarising an active period. For its lead asset, vididencel, long-term survival data from the ADVANCE II trial reinforce the drug’s potential as maintenance therapy in acute myeloid leukaemia (AML). We look forward to the launch of the Phase II CADENCE trial in Q124 to explore potential synergy with the standard of care (Onureg, oral azacitidine), which will be an important milestone. The interim results from this trial will guide plans for the pivotal stages of development. Management also shared updates on the ALISON trial (ovarian cancer) and the preparation of a Phase II trial for ilixadencel in soft tissue sarcomas (STS). Net cash was SEK119.9m at end FY23, which we estimate provides a runway through FY24. A slight adjustment in the launch of the AML trials is partially offset by the inclusion of a broader patient population (MRD+ and MRD-), rolling our model forward and FX, resulting in a valuation of SEK2.05bn or SEK2.38 per share (previously SEK2.18bn or SEK2.52 per share).

Year
end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/22

3.4

(138.8)

(0.70)

0.0

N/A

N/A

12/23

29.6

(101.6)

(0.22)

0.0

N/A

N/A

12/24e

0.0

(122.0)

(0.14)

0.0

N/A

N/A

12/25e

0.0

(125.9)

(0.15)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Key strategic focus: Vididencel combination trial

In Mendus’s year-end report, management emphasised that its strategic priority remains the upcoming CADENCE combination trial. Following the positive results of the ADVANCE II monotherapy trial (latest update presented in December 2023), which showed the potentially competitive profile of vididencel compared to the standard of care (Onureg, oral azacitidine), Mendus is now gearing up to explore the potential synergy between its lead cancer vaccine and Onureg in CADENCE. Patient enrolment is expected to commence in Q124 and we therefore expect the trial to run throughout 2024 and 2025. As its lead programme, interim updates and top-line results represent the next catalysts for Mendus.

Valuation: SEK2.05bn or SEK2.38 per share

Our underlying assumptions remain unchanged for vididencel in ovarian cancer and Ilixadencel in STS. However, as we have clarity on Mendus’s development plans, we adjust the target patient population and timelines for AML and now include the MRD- population, in addition to MRD+ (estimated launch in 2028 vs 2027 previously). After rolling our model forward and incorporating the latest net cash figure (SEK119.9m), our valuation adjusts to SEK2.05bn or SEK2.38/share (from SEK2.18bn or SEK2.52/share previously). Based on our cash burn projections, we estimate that the current cash position will be sufficient to fund operations through FY24. If the series TO3 warrants, vesting in March 2024 (issued alongside the August 2023 equity raise) are exercised fully (exercise price of SEK0.48m; currently out-of-money), an additional SEK90.6m should support runway extension to Q325. Otherwise, we estimate that Mendus will need to raise SEK125m in FY25, before signing a partnership deal in FY26.

A pipeline to improve survival for cancer patients

Mendus’s active clinical pipeline is focused on utilising its capabilities and experience in allogeneic cell therapies and dendritic cell biology to address serious unmet medical needs for cancer patients (Exhibit 1).

Exhibit 1: Clinical development pipeline

Source: Mendus FY23 report

Vididencel overview

The company’s lead asset, vididencel, is an off-the-shelf cellular immunotherapy, which is administered via intradermal injection. The product is derived from a proprietary leukemic cell line, which is rendered immunogenic by the cytokine-induced expression of dendritic cell costimulatory molecules. The final product is irradiated and stored frozen. On administration, vididencel is phagocytosed (‘eaten’) by skin-resident, antigen-presenting cells, which then trigger a broad immune response against known and unknown tumour antigens, such as WT1, RHAMM and PRAME. Because the product is based on a cell line, it allows for scalable, centralised manufacturing. Mendus has secured a manufacturing alliance with Sweden-based NorthX Biologics for large-scale manufacturing of vididencel in accordance with good manufacturing practice.

Mendus recently presented the long-term, follow-up data from its ADVANCE II trial, which explored vididencel as monotherapy in AML maintenance and, given the encouraging data, the next step for its clinical development is the upcoming CADENCE combination trial, expected to launch in H124. Vididencel is also being investigated as a potential maintenance therapy for ovarian cancer in the ongoing ALISON trial, for which updates are expected throughout H124.

Ilixadencel overview

The company’s second asset, ilixadencel, is an immune system primer comprising pro-inflammatory activated allogeneic dendritic cells intended for intratumoural administration. When injected into a tumour, these dendritic cells are expected to initiate local recruitment and activation of the patient’s dendritic cells, as well as natural killer cells and T-cells, to drive an anti-cancer response. Mendus completed long-term follow-up of the MERECA trial in metastatic renal cell carcinoma (mRCC) in December 2023. The data showed no significant survival difference between the ilixadencel plus sunitinib treatment arm versus the sunitinib-only control arm of the trial and management has decided not to pursue this indication further. However, the company is gearing up to launch a Phase II proof-of-concept trial in STS, expected to commence in H124.

Opportunity to differentiate in the AML maintenance setting

Mendus’s key strategic focus is the clinical development of vididencel as a potential disruptor in the AML maintenance setting. Patients diagnosed with AML initially go through induction chemotherapy, with the objective of killing as many leukaemia cells in the blood and bone marrow as possible. Chemotherapy-unfit patients are typically treated with venetoclax and azacitidine and, while some patients may achieve complete remission (CR) with such treatments, the risk of relapsing remains high for all AML patients. Maintenance therapies aim to completely eradicate residual cancer cells to reduce the probability of relapse, leading to durable clinical remissions.

An important concept in AML maintenance is that of measurable residual disease (MRD), which refers to the presence of cancer cells below the threshold of detectability for conventional testing methods. Therefore, a patient that has achieved CR may still be MRD positive (MRD+). MRD serves as a prognostic biomarker and represents a key relapse risk factor for AML patients.

Currently, allogeneic haematopoietic stem cell transplantation (allo-HSCT) is the only potentially curative treatment option for AML patients who have responded to initial therapy, but they must be healthy enough to undergo this procedure. The lack of a matched transplant donor also represents a key limitation with this treatment option. For patients ineligible for allo-HSCT, there are only two approved therapeutic options: Onureg, which is the current standard of care for AML maintenance, and Vanflyta, which was approved by the FDA for the treatment of AML patients carrying the FLT3-ITD mutation (c 37% of all AML patients) in July 2023. However, despite these therapeutic options, disease progression and relapse remain an ongoing medical need. Furthermore, safety is a key concern. Mendus is developing vididencel to address this, aiming to provide a safe and effective treatment option to prolong survival (Exhibit 2).

Exhibit 2: Vididencel targets the AML maintenance setting

Source: Mendus FY23 report

Immunotherapy holds promise as a desirable option for AML maintenance, as the approach is generally safe and has the potential to lead to durable clinical responses. However, while some immunotherapies, such as immune checkpoint inhibitors, have found success in extending survival for patients with solid tumours, in blood-based cancers such as AML their effectiveness has so far been limited (for example, nivolumab failed to improve survival in a Phase II study) and remains an ongoing clinical dilemma. To further corroborate this challenge, we highlight below some additional cases of recent failures in the clinic, including those from big pharma:

In February 2024, Gilead discontinued the development of magrolimab (an anti-CD47 antibody) in patients with AML (and myelodysplastic syndromes, MDS) after an increased risk of death was observed in a late-stage trial for the therapy.

In January 2024, Novartis ended its development efforts for MBG453 (an anti-TIM-3 antibody) following the results of its Phase III blood cancer trial, where it missed its primary endpoint; the therapy was being developed for AML and MDS.

Given the encouraging data to date for vididencel, it is our opinion that Mendus has a unique offering in an immunotherapy with the potential to improve AML patient outcomes.

Vididencel: Advancing survival for AML patients

The latest from the clinic

The most recent clinical programme for vididencel was the ADVANCE II trial, an international, multi-centre, open-label, proof-of-concept Phase II trial (n=20) investigating vididencel as monotherapy to prolong survival for AML patients, compared to Onureg (current standard of care). All patients included in this trial had initially achieved CR following induction chemotherapy, but all were MRD+.

The latest update came in the form of long-term survival data presented at the American Society of Hematology 2023 meeting (December 2023), demonstrating durable clinical remissions in the majority of patients following vididencel treatment. As of 24 November 2023, the median follow-up was 31.6 months (range of 6.6–60 months) and at this stage, median overall survival (OS) had not yet been reached, with 14/20 patients still alive and 11/14 patients still in CR (Exhibit 3). In terms of relapse-free survival (RFS), median RFS stood at 30.4 months and the RFS rate after two years was 56% (Exhibit 4). Estimated two-year and three-year OS rates were 74.9% and 64.7%, respectively.

Furthermore, immunomonitoring data, based on patient skin and blood samples collected as part of the trial, showed strong immune responses associated with the durable clinical remissions. We believe this supports vididencel’s mode of action as an immunotherapy with the potential to improve immunity against residual cancer cells. For more detail on both the survival and immunomonitoring data, please see our prior update note.

Exhibit 3: OS data from ADVANCE II

Exhibit 4: RFS data from ADVANCE II

Source: Mendus KOL event (14 December 2023)

Source: Mendus KOL event (14 December 2023)

Exhibit 3: OS data from ADVANCE II

Source: Mendus KOL event (14 December 2023)

Exhibit 4: RFS data from ADVANCE II

Source: Mendus KOL event (14 December 2023)

We note that Onureg is the only approved AML maintenance treatment. Its approval was based on the QUAZAR AML-001 trial, which included both MRD+ and MRD- AML patients. In this trial, for MRD+ patients, Onureg showed a median RFS of 7.1 months versus 2.7 months with placebo, and median OS of 14.6 months versus 10.4 months for placebo. For MRD- patients, median RFS was 13.4 months with Onureg versus 7.8 months with placebo, and median OS was 30.1 months with Onureg versus 24.3 months with placebo, demonstrating the differences in risk for MRD+ compared with MRD- patients. However, it is our opinion that the overall poor survival outcomes emphasise the need for improved maintenance therapies in AML, especially for patients unable to undergo allo-HSCT. We view Mendus’s forthcoming combination trial as an opportunity to strengthen the evidence of vididencel’s potential to provide a more effective treatment option.

CADENCE AML combination trial in focus

The upcoming ALLG AMLM22 CADENCE trial will be an adaptive, randomised, multi-centre Phase II clinical trial consisting of two stages, aiming to recruit a total of 140 patients. Importantly, the CADENCE trial will recruit both MRD+ and MRD- patients. This decision was made because relapse rates also remain high in MRD- AML patients, as we understand that false negatives are common in measurements of MRD, meaning that relapse is a risk for all AML patients. The decision to include both MRD+ and MRD- patients also ensures that the clinical development path for vididencel will follow the path taken by Onureg more closely, which we believe may help on the regulatory front. The first stage, involving 40 patients, will assess the safety of vididencel in combination with Onureg, compared to Onureg alone. The second stage will involve an additional 100 patients and aims to evaluate the efficacy of the combination. We note that management’s plans for a pivotal programme will likely be dependent on the interim readout of safety from the first 40 patients (Exhibit 5). In the combination treatment arm, patients will receive four biweekly intradermal injections of vididencel, followed by three booster injections up to six months after commencing treatment. All patients will be monitored over 18–24 months and we understand that management may expand the study into a pivotal trial, which could extend its duration by 24–36 months; however, this is subject to interim data being supportive. For the CADENCE trial, Mendus will benefit from the Australasian Leukaemia and Lymphoma Group’s (ALLG’s) experience in AML, as well as its clinical trial network, to ensure that the study progresses smoothly. In our view, the collaboration with ALLG represents a positive development in supporting the advancement of vididencel through the clinic.

Exhibit 5: Clinical development plan for vididencel in AML maintenance

Source: Mendus FY23 results presentation

Following the positive clinical data from ADVANCE II, we note that in November 2023 Mendus published a detailed overview and analysis of the Phase I vididencel clinical trial in HemaSphere. The publication provided additional insights into the encouraging potential of vididencel as a maintenance therapy for AML patients, while suggesting that the cancer vaccine may be combined with Onureg to provide better patient outcomes. In September 2023, vididencel was awarded Fast Track designation by the FDA as a potential maintenance therapy in AML. The benefits of Fast Track designation include more frequent interactions with the FDA for an expedited approval process and a ‘rolling review’ for its market application. Vididencel also benefits from orphan drug designation in the US and EU. We believe the above provides a strong foundation, both on clinical and regulatory fronts, for vididencel as a potential treatment option in the AML maintenance setting.

Ready for registrational studies with manufacturing in place

The CADENCE combination trial represents a strategic priority for Mendus and an important step forward in the clinical development of vididencel. We understand that interim data from this trial, as well as the previous ADVANCE II trial, will be used to inform the plan for registrational studies. Manufacturing is a key component of the preparation process, particularly in the cell-based therapies sector.

Vididencel is an off-the-shelf, non-patient-specific cancer vaccine. Importantly, the cell line-based approach with vididencel allows for scalable manufacturing, as the product may be frozen, which enables simple administration by intradermal injections. In our view, this offers a significant practical advantage, in contrast to patient-specific treatments that are associated with manufacturing bottlenecks, as it allows efficient patient access. To support this, Mendus has a manufacturing agreement with NorthX Biologics for the production of vididencel for both the upcoming CADENCE trial and subsequent potential registrational studies, as well as commercialisation. The agreement provides an opportunity to establish a dedicated facility to produce vididencel, putting Mendus in a strong position for the later stages of clinical development, in our view. We note that the manufacturing process for vididencel has been validated by an Advanced Therapy Medicinal Product certificate from the European Medicines Agency.

Clinical updates in ovarian cancer looming

Beyond AML, Mendus is focused on the clinical development of vididencel in ovarian cancer. In the ongoing Phase I ALISON trial (expected n=17), the cancer vaccine is being assessed as a monotherapy in ovarian cancer patients after primary treatment. The primary endpoint of the study is the number of patients with vaccine-induced antigen-specific T-cell responses (VIRs) following treatment.

The latest update, presented at the Society for Immunotherapy of Cancer Annual Meeting (1–5 November 2023) showed that nine of the 13 patients enrolled had completed treatment (up to week 22) and nine of the 13 were still alive, with four of the 13 patients showing disease recurrence prior to week 22. Of the eight evaluable patients, six showed VIRs (75%). Furthermore, immune responses against tumour-associated antigens absent in vididencel were also observed, suggesting that vididencel may elicit broader immune responses than initially anticipated. While we acknowledge that the interim readouts represent a small sample size, we believe the immune responses are an encouraging indicator that the trial is on track to meet its primary endpoint.

Patient enrolment for ALISON was announced as complete in the company’s end-of-year pipeline update. We expect further readouts from the ALISON trial throughout 2024, including a detailed analysis of the survival data in H224.

Ilixadencel: Clinical progression ahead

MERECA trial in mRCC completed

In December 2023, Mendus announced the completion of the Phase II MERECA trial, an international, multi-centre, open-label, randomised study to assess the safety and efficacy of ilixadencel in mRCC (n=86). Of the 86 patients enrolled, 56 were treated with ilixadencel (intratumoural administration) followed by surgery (kidney tumour removal) and standard treatment with sunitinib; the remaining 30 patients were treated with sunitinib only. However, the long-term results showed no significant survival differences between the treatment and control arms. While median OS was 35.6 months with ilixadencel versus 25.3 months with the control, at five years post-treatment 32.1% of the patients in the ilixadencel group were still alive, compared to 26.7% in the control group. While the results were in favour of ilixadencel treatment, the lack of statistical significance has led management to decide not to pursue mRCC further. However, Mendus will continue the clinical development of ilixadencel in STS.

Next opportunity: STS

Mendus is gearing up to commence a Phase II trial for ilixadencel in STS, as management believes there is a greater opportunity in this group of tumours, which appear more challenging to manage with immunotherapies. Mendus has already received Fast Track and orphan drug designations from the FDA. The upcoming proof-of-concept Phase II study in STS aims to confirm clinical efficacy and safety in a relatively limited number of patients, and is expected to commence in H124. We believe that readouts from this trial could define the potential of ilixadencel and expect updates as the trial progresses throughout 2024.

Financials

As a pre-revenue company, Mendus does not report any revenues. In FY23, it reported other operating income of SEK29.6m (FY22: SEK3.4m), primarily related to patent transfer revenue and grants for the previously charged innovation loan from the Dutch enterprise agency RVO. Total operating expenses decreased by 5% during the year to SEK130.3m (FY22: SEK137.1m), although the figure was above our estimate of SEK120.5m. R&D activity picked up pace in Q423 (expenses of SEK37m versus SEK28m in Q422), driving the full-year expense to SEK92.7m (FY22: SEK87.0m). Notably, R&D as a percentage of operating expenses rose to 71% during the year versus 64% in FY22. We attribute this to increasing investments in preparation for the upcoming ALLG AMLM22 CADENCE trial for lead drug vididencel in combination with the standard of care Onureg, which is expected to commence in Q124, as well as a new Phase II trial evaluating the second asset, ilixadencel, in a new indication, STS, of which gastrointestinal stromal tumours (GIST) is a subset (trial expected to start in H124). General and administrative expenses declined by 24% to SEK37.1m (FY22: SEK48.9m). Operating loss improved to SEK100.7m (FY22: SEK133.7m), although the bulk of this improvement can be attributed to the contribution from other operating income. In contrast to the improvement in operating loss, cash outflow from operating activities increased to SEK166.4m, up 52% over SEK109.3m in FY22. This can be attributed to SEK64.4m in prepaid expense incurred by Mendus for the vididencel programme over the year.

We have made very minor adjustments to our FY24 estimates based on Mendus’s FY23 performance and increased visibility on the company’s plans for its pipeline assets. We raise our R&D estimates slightly (SEK85.4m vs SEK84.8m previously), but maintain our estimates for general and administrative expenses at SEK34m. Overall, our operating loss estimates improve slightly to SEK121.2m (SEK123.5m previously). We also introduce FY25 estimates, projecting an operating loss of SEK124.9m, primarily driven by higher R&D expenses assumed for the year.

Mendus ended the year with a net cash position of SEK119.9m (gross cash of SEK120.8m adjusted for SEK0.85m in debt from Region Västra Götaland as conditional credits), supported by the SEK317m (gross) fund-raise in August 2023 through a combination of a rights issue (SEK227m) and a directed issue to Flerie Invest (SEK90m). Additionally, the company paid off the SEK50m shareholder loan to Van Herk Investments via a debt-to-equity conversion as part of the financing transaction. We expect the current cash position to provide a runway through FY24, past the initiation of clinical trials in AML and STS and Phase I readout from the ALISON study evaluating vididencel in ovarian cancer (expected in H224). As part of the August 2023 funding, Mendus had also issued attached warrants (TO3), which vest between 15 and 29 March 2024 and can be converted at a price of SEK0.48/share. Full conversion could net the company SEK90.6m in additional proceeds, although we note that the warrants remain out-of-money as of now (current share price SEK0.43). If converted fully, we estimate that the additional capital will extend the company’s runway through Q325. Management had previously indicated that, if available, these additional funds will also be utilised to conduct a futility analysis of the CADENCE combination trial (vididencel + Onureg). As indicated above, the combination trial is expected to continue for 18–24 months from its initiation timeline of Q124 and we therefore assume that Mendus will be able to finalise a licensing deal by FY26. Assuming no contribution from the warrants exercise, we estimate that Mendus will need to raise another SEK125m in funding in FY25. Should the licensing deal not come through, the company will be required to raise a combined SEK300m through FY26 and FY27, according to our calculations.

Valuation

Our valuation for Mendus is based on a sum-of-the-parts calculation of its clinical programmes and includes an rNPV calculation for vididencel in AML and ovarian cancer, and ilixadencel in STS (our model assumes GIST as a specific indication based on the company’s initial data). With increased clarity from management on the likely clinical pathway for Mendus’s assets, we have revisited our valuation assumptions for all three clinical programmes. While we maintain our underlying assumptions (patient populations, launch timelines and probability of success) for vididencel in ovarian cancer and ilixadencel in GIST, we have now expanded the target patient population for vididencel in AML in our model to include MRD- patients (in addition to MRD+ patients previously), highlighted by management at the KOL event held in December 2023 (please see our prior note for more detail). This changes our peak sales estimates to $980m for vididencel in AML maintenance (vs $680m previously). However, we have conservatively extended the launch timeline for the treatment by a year, to 2028 from 2027 previously. This is driven by clarity on the plans for the Phase II combination study with Onureg which, as explained above, is expected to last 18–24 months. Mendus has indicated that, based on the ADVANCE II and CADENCE trial data, it will seek to finalise a registration path for vididencel in 2025. We keep our probability of success unchanged for this indication as we believe that data from both the monotherapy and combination trials should support effective labelling of the drug, which will dictate eventual commercial success. Overall, we adjust our valuation for Mendus to SEK2.05bn or SEK2.38/share (from SEK2.18bn or SEK2.52/share previously). This includes the benefit from rolling forward our model and adjusting for the latest net cash figure of SEK119.9m. A breakdown of our valuation is shown in Exhibit 6.

Exhibit 6: Mendus rNPV valuation

Product

Indication

Launch

Peak sales
($m)

NPV
(SEKm)

Probability of success

rNPV
(SEKm)

NPV/share
(SEK/share)

Vididencel (DCP-001)

AML

2028

980

4,218

20.0%

922

1.07

Vididencel (DCP-001)

OC

2031

760

2,496

15.0%

757

0.88

Ilixadencel

GIST

2029

230

1,686

15.0%

253

0.29

Net cash at 31 December 2023

119.9

100.0%

119.9

0.14

Valuation

 

 

 

8,520

 

2,052

2.38

Source: Edison Investment Research

As indicated above, assuming Mendus takes its assets to commercialisation on its own, we estimate that it will need to raise a total of SEK425m between FY25 and FY27 before reaching profitability in 2028. If this is actioned through an equity issue, the company will be required to issue 988.4m shares (at the current share price of SEK0.43), which will lead to the total number of shares outstanding increasing to 1.85bn and our per-share valuation diluting to SEK1.03/share.

Exhibit 7: Financial summary

Accounts: IFRS, year-end: 31 December; SEK’000s

2022

2023

2024e

2025e

INCOME STATEMENT

 

 

 

 

Total revenue

3,375

29,613

0

0

Cost of sales

0

0

0

0

Gross profit

3,375

29,613

0

0

SG&A (expenses)

(44,028)

(26,178)

(34,031)

(35,052)

R&D costs

(87,049)

(92,653)

(85,438)

(88,106)

Other income/(expense)

(1,134)

(559)

0

0

Exceptionals and adjustments

0

0

0

0

Reported EBITDA

(128,836)

(89,777)

(119,470)

(123,159)

Depreciation and amortisation

(4,848)

(10,873)

(1,776)

(1,776)

Reported Operating Profit/(loss)

(133,684)

(100,650)

(121,245)

(124,934)

Finance income/(expense)

(5,101)

(968)

(789)

(988)

Other income/(expense)

 

 

 

 

Exceptionals and adjustments

0

0

0

0

Reported PBT

(138,785)

(101,618)

(122,034)

(125,922)

Adjusted PBT

(138,785)

(101,618)

(122,034)

(125,922)

Income tax expense

0

0

0

0

Reported net income

(138,785)

(101,618)

(122,034)

(125,922)

Basic average number of shares, m

199.4

461.9

863.1

863.1

Basic EPS (SEK)

(0.70)

(0.22)

(0.14)

(0.15)

Diluted EPS (SEK)

(0.70)

(0.22)

(0.14)

(0.15)

BLALANCE SHEET

 

 

 

 

Property, plant and equipment

13,899

11,197

9,421

7,646

Intangible assets

532,441

532,441

532,441

532,441

Right of use assets

26,216

23,247

23,247

23,247

Other non-current assets

618

624

624

624

Total non-current assets

573,174

567,509

565,733

563,958

Cash and equivalents

41,851

120,782

524

1,377

Prepaid expenses and accrued income

1,919

64,359

64,359

64,359

Other current assets

3,442

3,302

3,302

3,302

Total current assets

47,212

188,443

68,185

69,038

Non-current loans and borrowings

22,845

850

850

125,850

Non-current lease liabilities

23,706

21,115

21,115

21,115

Total non-current liabilities

46,551

21,965

21,965

146,965

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

20,375

18,608

18,608

18,608

Total current liabilities

59,397

29,260

29,260

29,260

Equity attributable to company

514,438

704,727

582,693

456,771

CASH FLOW STATEMENT

 

 

 

 

Operating Profit/(loss)

(133,684)

(99,471)

(121,245)

(124,934)

Depreciation and amortisation

4,848

10,873

1,776

1,776

Other adjustments

(6,390)

(8,178)

0

0

Movements in working capital

27,030

(65,479)

0

0

Interest paid / received

(1,135)

(4,148)

(789)

(988)

Income taxes paid

0

0

0

0

Cash from operations (CFO)

(109,331)

(166,404)

(120,258)

(124,146)

Capex

(12,324)

0

0

0

Acquisitions & disposals net

0

0

0

0

Other investing activities

0

10,203

0

0

Cash used in investing activities (CFIA)

(12,324)

10,203

0

0

Net proceeds from issue of shares

0

297,904

0

0

Movements in debt

8,194

(60,518)

0

125,000

Other financing activities

0

0

0

0

Cash flow from financing activities

8,194

237,386

0

125,000

Increase/(decrease) in cash and equivalents

(113,461)

81,185

(120,258)

854

Cash and equivalents at beginning of period

155,313

41,851

120,782

524

Cash and equivalents at end of period

41,851

120,782

524

1,377

Net (debt)/cash

(10,192)

119,932

(326)

(124,473)

Source: Company reports, Edison Investment Research

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Copyright: Copyright 2024 Edison Investment Research Limited (Edison).

Australia

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United Kingdom

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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

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 2024 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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