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Mendus
Quarterly Report • May 17, 2024
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Quarterly Report
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Significant events of Q1 2024
- » Net sales for the period amounted to KSEK (-)
- » Result for the period amounted to KSEK -35,614 (-30,169)
- » Earnings and diluted earnings per share totaled SEK-0.04 (-0.15)
- » Mendus provided a business update that included that preparations for the registration study with vididencel are ongoing after positive initial feedback from the FDA, the manufacturing alliance with NorthX Biologics is progressing according to plan, and the collaboration with ALLG is progressing according to previous guidance with expected start of the AMLM22-CADENCE trial in April 2024
- » Mendus announced that the company had received declarations of intent from major owners and the board of directors as well as company management regarding the exercise of warrants of series TO3, which in total is expected to result in the exercise of approximately 71.6 percent of the outstanding warrants. The exercise period for the warrants began on March 15, 2024
- » Mendus presented the progress of its NK cell program at the 9th Annual Innate Killer Cell Summit, a leading conference for NK cell-based therapies
- » Mendus announced Human Research Ethics Committee (HREC) approval to initiate the AMLM22-CADENCE trial, which studies Mendus' lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML)
Significant events after end of period
» Mendus announced in April that the company raised approximately SEK 69.1 million through the warrants of series TO3. In total, 144,043,202 warrants were exercised, corresponding to approximately 76.3 percent of the total number of outstanding warrants
Financial summary
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| Amounts in KSEK | Jan - Mar | Jan - Mar | Jan - Dec |
| Revenue | – | – | – |
| Operating profit/loss | -35,317 | -29,609 | -100,650 |
| Net profit/loss | -35,614 | -30,169 | -101,619 |
| Earnings/loss per share, before and after dilution (SEK) | -0.04 | -0.15 | -0.22 |
| Cash | 88,186 | 37,496 | 120,781 |
| Shareholders equity | 672,131 | 487,791 | 704,727 |
| Number of employees | 30 | 33 | 30 |
CEO Comment
First steps taken towards late-stage development of vididencel
VD har ordet In the first quarter of 2024, Mendus made significant progress with its lead program vididencel in acute myeloid leukemia (AML).
In March, we were pleased to present a business update together with our partners NorthX Biologics (NorthX) and Australiasian Leukaemia and Lymphoma Group (ALLG), confirming that both partnerships are on track. Also in the first quarter, we received positive FDA feedback on the proposed steps to prepare for late-stage development of vididencel in AML, including the implementation of large-scale manufacturing together with NorthX. Based on the timelines for clinical trial protocol development, including interactions with regulatory agencies, and the manufacturing of the first large-scale GMP batches of vididencel at NorthX, Mendus expects vididencel to be ready for pivotalstage development in AML in the second half of 2025. The preparations for late-stage clinical development are supported by vididencel's extensive regulatory dossier.
Ethics committee approval cleared the path for the start of the Phase 2 AMLM22-CADENCE trial, a trial carried out in collaboration with ALLG. The CADENCE trial will study vididencel as a maintenance treatment for AML in combination with oral azacitidine, currently the only approved AML maintenance drug. Next to the
positive data already reported for the ongoing ADVANCE II trial, the data from the CADENCE trial will contribute to the global registration dossier of vididencel in AML.
Manufacturing of the first large-scale GMP batches of vididencel at NorthX Biologics.
On March 15, 2024, the exercise period started for the TO3 warrants, which were issued as part of the July 2023 financing round. Mendus' largest shareholders, as well as the management team and members of the board confirmed their intention to exercise their warrant holdings. In total, around 76 percent of the outstanding warrants were exercised, resulting in approximately SEK 69 million of proceeds, which will extend the cash runway of the company, based on current activities, until the third quarter
of 2025.
Mendus' second clinical-stage product, the intratumoral immune primer ilixadencel, has been prepared for a new Phase 2 trial in soft tissue sarcomas and Mendus is currently in advanced discussions with potential collaborators to perform such a trial. Progress made with Mendus' preclinical NK cell program, based on tumor cell killing experiments and manufacturing process development, was presented at the annual Innate Killer Summit.
Based on increasing clinical success, cancer vaccines are attracting new interest as a therapeutic modality, particularly for low-disease settings. Mendus is part of that next wave of innovation in cancer immunotherapy and we remain committed to changing the course of cancer treatment, by developing novel immunotherapies that prolong disease-free and overall survival, without harming health or quality of life. We thank all our stakeholders for their continued support.
Erik Manting, Ph.D.
Chief Executive Officer
Mendus in short
Mendus is developing novel cancer therapies based on harnessing the power of the immune system to control residual disease and prolong disease-free and overall survival of cancer patients, without harming health or quality of life.
Cancer treatment without harming health or quality of life.
Changing the course of cancer treatment
In today's cancer therapy landscape, many cancer patients experience an initial treatment success, leading to clinical remission. However, tumor recurrence remains an imminent threat in many cases and causes the vast majority of cancer-related deaths today. As a result, there is an increasing need for maintenance therapies, particularly in tumor indications with a high recurrence rate.
Vididencel – positioned as a novel maintenance therapy in AML
Vididencel is an immunotherapy derived from the company's proprietary DCOne cell line. During manufacturing, the DCOne cells, which have a leukemic origin, undergo a phenotypic shift to express dendritic cell phenotype. This renders the cells highly immunogenic and suitable as the basis for vididencel. Vididencel is an off-theshelf product, which is stored frozen, is available on-demand and can be administered via intradermal injection. Promising clinical data with vididencel were presented at various high-profile medical conferences. The results consistently demonstrated vididencel's ability to induce durable immune responses, combined with an excellent safety profile. The clinical development of vididencel in AML is supported by Orphan Drug status (EU + US)
and Fast Track Designation (US). The vididencel manufacturing process has been validated by an ATMP certificate issued by EMA.
The ongoing ADVANCE II Phase 2 monotherapy trial evaluates single-agent activity of vididencel as maintenance therapy in AML, for patients brought into complete remission through chemotherapy, but with measurable residual disease (MRD). The presence of MRD puts patients at a high risk of relapse and reduced overall survival.
Mendus presented positive survival data from the ADVANCE II trial in December 2023 at the ASH conference. At a median follow-up of 31.6 months, 14/20 patients were alive, with 11 still in first complete remission. Median relapse-free survival stood at 30.4 months (2,5 years). Immunomonitoring and MRD data confirmed that vididencel acts as an immunotherapy that improves active immunity, built up by the patients' own immune system, against residual cancer cells.
The ADVANCE II monotherapy proofof-concept data support the broader positioning of vididencel as a new treatment modality in AML maintenance. As a first step-up to pivotalstage development, vididencel will be combined in a next clinical trial with oral azacitidine, the only approved maintenance therapy for transplantineligible AML patients. For this, Mendus announced that in December 2023 it has entered into a collaboration with the Australasian Leukaemia & Lymphoma Group (ALLG).
In parallel to the continued clinical development, Mendus will implement a large-scale manufacturing process and expand the manufacturing infrastructure for vididencel. In 2023, Mendus has entered into a strategic manufacturing alliance with NorthX Biologics, a leading Contract Development and Manufacturing Organization (CDMO) in the Nordics, which also serves as the National Swedish Innovation Hub for the GMP manufacture of biologics used in vaccines, gene therapy and other advanced therapy medicinal products (ATMPs). Mendus and NorthX will co-establish cell therapy manufacturing capabil"Vididencel has the potential to induce durable clinical responses and it has a strong safety profile, which are the two most important aspects for a successful maintenance therapy"
JEROEN ROVERS, Chief Medical Officer
ities in Sweden, which will be used for late-stage clinical development and commercial manufacturing of vididencel.
Indication expansion – ovarian cancer
Like AML, ovarian cancer is characterized by fast tumor recurrence following initial treatment, providing for the rationale to develop maintenance therapy options in this disease. Supported by preclinical data demonstrating vididencel's potential to stimulate anti-tumor immunity in ovarian cancer, the currently active and recruiting ALISON Phase 1 clinical trial explores safety and feasibility of vididencel as
a maintenance treatment in ovarian cancer.
Interim data from the ALISON trial presented at the most recent AACR, CICON and SITC conferences confirmed vididencel's excellent safety profile and demonstrated improved immune responses against tumor antigens previously shown to be relevant for ovarian cancer following vididencel administration. The ALISON trial was fully recruited in December 2023 and Mendus expects to report additional clinical data from the ALISON trial in 2024, including a primary read-out in 2024H2.
The vast majority of cancer-related deaths is due to recurrence of the disease, caused by residual cancer cells. Vididencel is designed to boost immunity against residual cancer cells, to improve disease-free and overall survival following first-line treatment of the primary tumor.
llixadencel – an intratumoral immune primer for hard-to-treat solid tumors
Ilixadencel consists of dendritic cells derived from healthy donor material, which are administered as an intratumoral injection to produce an inflammatory local environment and ultimately a tumor-specific immune response.
Ilixadencel has been studied in clinical trials across a range of solid tumor indications in combination with existing cancer therapies, including tyrosine kinase inhibitors and the immune checkpoint inhibitor pembrolizumab. Preclinical results furthermore suggest synergies with other immune checkpoint modulators, including antibodies directed
towards CTLA-4 and 4-1BB. Overall, a substantial body of preclinical and clinical data underscore ilixadencel's potential as a safe and viable combination therapy in cancer therapy. Mendus aims to establish proof-ofconcept data with ilixadencel in soft tissue sarcoma's, a group of tumors that is poorly responding to current available therapies.
Preclinical pipeline
Next to supporting the clinical pipeline programs and manufacturing of the company's product candidates, Mendus' research activities include the design of next-generation immune primers based on the DCOne cell line as well as leveraging internal pipeline synergies through the combination of vaccination and intratumoral priming.
Mendus has also applied its expertise in dendritic cell biology to improve other cell-based therapies. Particularly, Mendus has explored the application of the proprietary DCOne platform to expand memory NK cells, an important subset of NK cells because of their longevity, resistance to immune suppression and correlation with improved clinical outcomes in blood-borne tumors in particular. Establishing a method to expand therapeutic quantities of memory NK cells may therefore provide the basis for novel, improved NK cell-based therapies, to potentially enter the Mendus pipeline.
'It is all about preparedness'
Interview with SVEN ANDREASSON, independent board member
Following positive Phase 2 data, Mendus is preparing for late-stage development of its lead product vididencel. What does that mean and what are the main considerations when a biotechnology company enters into such a next phase of development?
Who to better ask than Sven Andreasson, independent board member and incoming Chairman at Mendus? Sven has extensive experience from the pharmaceutical and biotech industry both from "Big Pharma" and large and small Biotech companies and has seen the biopharmaceutical industry from all angles. He had different senior management positions at Pharmacia, before switching to biotech and serving in different executive and non-executive management roles. Sven is currently living in Washington DC, USA, and is planning to spend more time and eventually moving back to Stockholm in the near future.
Sven, how would you describe your extensive career?
SA: With a financial background, I was early fascinated by the pharmaceutical industry, being dependent on new discoveries and break-throughs in a high risk/high reward sector and at the same time the need to deliver sound strategies, economics and financials to create sustainable shareholder value. Following close to 25 years in
pharma, in different executive global management roles at Pharmacia, I took the step to the biotech sector and have been part of it since. Between 1999 and 2013 I have mainly had CEO roles in public and private biotech companies, sequentially at
Active Biotech in Sweden, Beta-Cell in Belgium and Isconova, a public vaccine development company which was sold to the US public vaccine company Novavax. In connection with this acquisition, I assumed the role as Senior Vice President
at Novavax, with responsibility for Corporate and Business development. I have also supported many companies in different board roles among others Cantargia, TiGenix, Erytech and of course Immunicum, which later became Mendus. You could say I have seen quite a bit of the biotechnology sector, with focus on Europe and the US, over the many years I have been involved in this fascinating area.
How do you see Mendus today from your position as board member?
SA: Mendus today is a very different company from when I first joined as board member in 2020. At the time, the company was still called Immunicum and had one particular asset, the intratumoral primer ilixadencel, designed to improve immunity against solid tumors. At the end of 2020, we recommended as the board of Immunicum a merger between Immunicum and DCprime BV, a private Dutch company that was specialized in dendritic cell biology, just like Immunicum. The reason the Board was in favor of the merger was that it would result in a stronger company, based on multiple product candidates. Also, DCprime had built up research and manufacturing process development expertise which was complementary with Immunicum's know-how and technology basis. This was very important, because
it allowed us to further optimize our product candidates, including the ilixadencel production process. With DCprime came Van Herk Investments in Rotterdam as a large majority shareholder and it has been a pleasure to work with them. The same holds true for the Dutch board members Andrea van Elsas, Hans Preusting and Dharminder Chahal, who joined me and the other Swedish board members Christine Lind and Helén Tuvesson after the merger. It was great to see how the board, the combined management team and the company as a whole came together after the merger under the experienced helm of Erik Manting as CEO. Christine Lind will now leave the board, to assume the CEO role at Bactiguard and, subject to shareholder approval, I will take over as Chairman of the board. Andrea van Elsas has joined a large investment firm, Third Rock Ventures, and has moved permanently to the US, so he will also leave the board to fully focus on his new position. We are grateful to both, as they have been very valuable board members in the past years.
What are the next steps for the company and how will Mendus benefit from your experience?
SA: Mendus has pursued a path focused on the high unmet medical need for novel cancer maintenance therapies and we are now starting
to see very promising evolving data in acute myeloid leukemia or AML, with the majority of patients being alive in the long-term follow-up of our ongoing Phase 2 trial. To translate and execute such a promising data finding into a late-stage development strategy with the objective to follow the regulatory path leading to product approval and commercial success is now our company challenge. In parallel to the clinical development of vididencel, we are focusing and investing in the buildup of manufacturing and regulatory preparedness. Mendus has put a lot of research and development effort into optimizing the manufacturing process of vididencel and we are very happy that we could close an alliance with NorthX Biologics in 2023. This allows for the implementation of large-scale manufacturing to support further late-stage clinical development and, eventually, commercial launch. It is about preparedness on all fronts and I will strive to emphasize and support this as much as possible together with the whole board and management. In addition, I bring my business development expertise and network, which I am gladly sharing with the company. The foundation of the company today is a strong one and with the promising data we have in our clinical pipeline, I look forward to be part of the next phase of its journey.
Financial information
The Group
Revenue
No turnover was reported for the first quarter - (-). Other operating income amounted to KSEK 2,784 (286) and mainly consisting of revenue from patent transfers and research grant from Oncode PACT.
Operating expenses
The total operating costs for the quarter amounted to KSEK -38,101 (-29,895). Operating expenses were associated with administrative and R&D expenses for the DCOne® platform and the vididencel and ilixadencel programs.
Research and development costs
Research and development costs for the quarter amounted to KSEK -29,018 (-19,782). The costs consist mainly of research and development costs for the DCOne® platform as well as the programs for vididencel and ilixadencel.
Administrative expenses
Administration expenses amounted to KSEK -8,985 (-9,914). Included administrative (G&A) costs are mainly attributable to the finance department, corporate management and costs related to activities related to financing and investor relations.
Result
Operating profit amounted to KSEK -35,317 (-29,609) for the first quarter. The net result amounted to KSEK -35,614 (-30,169). The deteriorated result is mainly due the fact that the Group has had increased research and development costs for Tech transfer to NorthX.
Earnings per share before and after dilution for the Group amounted to SEK -0.04 (-0.15).
Tax
No tax was reported for the first quarter – (-).
Cash flow, investments and financial position
The cash flow from operating activities for the first quarter amounted to KSEK -30,615 (-33,554). The negative cash flow is according to plan and is mainly explained by a large prepaid expense in Mendus B.V. relating to the vididencel program.
During the quarter, cash flow from investing activities amounted to KSEK -1,354 (-495). The cash flow from financing activities amounted to KSEK -932 (29,687).
As of March 31, 2024, the Group's cash and cash equivalents amounted to KSEK 88,186 (37,496).
Total equity as of March 31, 2024 amounted to KSEK 672,131 (487,791), corresponding to SEK 0.78 (2.42) per share. The company's solvency at the end of the quarter is 94% (79%).
Financial information
Parent Company Mendus AB
Revenue
No turnover was reported for the first quarter – (-). Other operating income amounted to KSEK 1,584 (1,148) and consisted mainly of pass-through costs to Mendus B.V and revenue for patent transfer.
Operating expenses
Total operating expenses for the quarter amounted to KSEK -10,653 (-11,513). Operating expenses were related to administrative expenses and R&D expenses for ilixadencel.
Research and development costs
Research and development costs for the quarter amounted to KSEK -3,848 (-3,133). The costs consist mainly of activities relating to clinical studies.
Administrative expenses
Administrative expenses for the quarter amounted to KSEK -6,720 (-8,209). Included costs within administrative (G&A) are mainly attributable to the finance department, corporate management and costs related to financing and investor relations activities. The company has had lower costs for external advisors and consultants during the current year, compared with the previous year.
Result
Operating profit amounted to KSEK -9,069 (-10,365). The net result amounted to KSEK -9,067 (-10,609).
Earnings per share before and after dilution for the parent company were SEK -0.01 (-0.05).
Tax
No tax was reported for the first quarter – (-).
Cash flow, investments and financial position
The cash flow from operating activities for the quarter amounted to KSEK -9,772 (-11,101). The continued negative cash flow is according to plan and is mainly explained by the fact that the company is in a development phase.
Cash flow from investing activities amounted to KSEK -10,454 (-14,818). The cash flow is primarily attributable to shareholder contributions to Mendus B.V. The cash flow from financing activities amounted to KSEK - (28,191).
As of March 31, 2024, the company's cash and cash equivalents amounted to KSEK 80,200 (30,357).
Total equity as of March 31, 2024, amounted to KSEK 976,858 (714,557), corresponding to SEK 1.13 (3.55) per share. The company's solvency at the end of the first quarter was 99% (93%).
Other information
Incentive
The purpose of share-based incentive programs is to promote the company's long-term interests by motivating and rewarding the company's senior executives and other employees in line with the interests of the shareholders. There are currently two active programs in the company.
LTI 2021/2024
In accordance with a decision by the Annual General Meeting on May 4, 2021, it was resolved to introduce an incentive program with warrants and restricted shares; "LTI 2021/2024".
The number of subscribed share rights amounted to 680,000. During 2021-2023, a total of 261,000 share rights have been forfeited in connection with employees leaving. This brings the number of restricted shares issued amounted to 419,000. The part of the program that related to warrants has been terminated prematurely and all options have been recalled.
LTI 2022/2025
In accordance with a decision by the Annual General Meeting on May 2022, it was resolved to introduce an incentive program with warrants; "LTI 2022/2025".
The program has been terminated prematurely and all warrants have been revoked.
LTI 2023/2027
At an Extraordinary General Meeting on December 13, 2023, it was decided to introduce an incentive program with warrants. The number of warrants amounted to 47,333,226.
For more information about the programs, see the minutes from the Annual General Meeting 2021, 2022 and from the Extraordinary General Meeting 20231213 published on the company's website www.mendus.com.
Employees
As of March 31, 2024, the Group had 28 (33) employees, of whom 18 (22) were women and 10 (11) men.
Mendus Share
The share is traded on Nasdaq Stockholm's main market under the ticker IMMU, with ISIN code SE0005003654. As of March 31, the number of shares in the company amounted to 863,148,371 (201,311,406) and the share capital in the company amounted to KSEK 43,157 (10,066). All shares have equal voting rights and a share of Mendus' assets and profits.
Shareholders as of 2024-03-31
Source: Euroclear Sweden
| % of votes | ||
|---|---|---|
| Owners | Shares | and capita |
| Adrianus Van Herk | 298,544 464 | 34.59% |
| Flerie Invest AB | 187,500,000 | 21.72% |
| Fourth Swedish National Pension Fund | 81,999,089 | 9.50% |
| Avanza Pension | 9,112,305 | 3.37% |
| Holger Blomstrand Byggnads AB | 12,988,860 | 1.50% |
| Nordnet Pension Insurance | 7,338,180 | 0.85% |
| SEB Funds | 6,620,661 | 0.77% |
| Staffan Wensing | 6,277,671 | 0.73% |
| Handelsbanken Funds | 5,134,020 | 0.59% |
| Erik Manting | 4,668,242 | 0.54% |
| Dharminder Chahal | 4,410,241 | 0.51% |
| Bilsen Begovic | 3,061,078 | 0.35% |
| Christer Isberg | 2,654,309 | 0.31% |
| FCG Funds | 2,370,039 | 0.27% |
| Fredrik Svedeback | 2,311,000 | 0.27% |
| Lotta Ferm | 2,200,000 | 0.25% |
| Handelsbanken Liv Försäkring | 2,108,955 | 0.24% |
| Reda Jadile | 2,001,184 | 0.23% |
| Lars Inge Thomas Nilsson | 1,894,981 | 0.22% |
| Martin Lindström | 1,875,000 | 0.22% |
| Others | 198,078,092 | 22.95% |
| Total | 863,148,371 | 100% |
Review
This report has not been reviewed by the company's auditor.
FINANCIAL REPORTS THE GROUP
Consolidated income statement
| Amounts in KSEK | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
|---|---|---|---|
| Revenue | – | – | – |
| Other operating income | 2,784 | 286 | 29,613 |
| Total revenue and other operating income | 2,784 | 286 | 29,613 |
| OPERATING EXPENSES | |||
| Administration expenses | -8,985 | -9,914 | -37,051 |
| Research and development expenses | -29,018 | -19,782 | -92,653 |
| Other operating expenses | -98 | -199 | -559 |
| Operating profit/loss | -35,317 | -29,609 | -100,650 |
| RESULT FROM FINANCIAL ITEMS | |||
| Financial income | 3 | – | 2,147 |
| Financial costs | -300 | -560 | -3,115 |
| Profit/loss after financial items | -35,614 | -30,169 | -101,619 |
| TOTAL PROFIT/LOSS BEFORE TAXES | -35,614 | -30,169 | -101,619 |
| Income tax | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -35,614 | -30,169 | -101,619 |
| Earnings/loss per share before and after | |||
| dilution (SEK), for profit attributable to owner | |||
| of the parent company´s shareholders. | -0.04 | -0.15 | -0.22 |
Consolidated statement of comprehensive income
| Amounts in KSEK | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
|---|---|---|---|
| Result for the period | -35,614 | -30,169 | -101,619 |
| Other comprehensive income | – | – | – |
| Exchange differences on translation | |||
| of foreign operations | 2,430 | 178 | -5,403 |
| Other comprehensive income for the period | 2,430 | 178 | -5,403 |
| Total comprehensive income for the period | -33,185 | -29,991 | -107,022 |
Profit/loss for the period and total comprehensive income, are in their entirety attributable to the parent company's shareholders.
Consolidated balance sheet statement
| Amounts in KSEK | 2024-03-31 | 2023-03-31 | 2023-12-31 |
|---|---|---|---|
| ASSETS | |||
| NON-CURRENT ASSETS | |||
| Goodwill | 108,350 | 108,350 | 108,350 |
| Technology | 424,091 | 424,091 | 424,091 |
| Right-of-use assets | 23,394 | 25,829 | 23,247 |
| Equipment | 10,727 | 13,516 | 11,197 |
| Other long term receivables | 633 | 621 | 624 |
| Total Non-current assets | 567,196 | 572,407 | 567,509 |
| CURRENT ASSETS | |||
| Other receivables | 3,450 | 3,086 | 3,302 |
| Prepaid expenses and accrued income | 56,102 | 2,808 | 64,359 |
| Cash and cash equivalents | 88,186 | 37,496 | 120,782 |
| Total current assets | 147,738 | 43,390 | 188,443 |
| TOTAL ASSETS | 714,934 | 615,798 | 755,952 |
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 43,157 | 10,066 | 43,157 |
| Additional paid-in capital | 1,395,347 | 1,133,875 | 1,394,758 |
| Reserves | -3,155 | 3 | -5,584 |
| Retained earnings (including profit/loss for the period) | -763,218 | -656,153 | -727,604 |
| Total equity attributable to the shareholders | |||
| of the parent company | 672,131 | 487,791 | 704,727 |
| LIABILITIES | |||
| Non-current liabilities | |||
| Other long-term liabilities | 850 | 28,342 | 850 |
| Lease liabilities | 21,558 | 23,690 | 21,115 |
| Total non-current liabilities | 22,408 | 52,032 | 21,965 |
| CURRENT LIABILITIES | |||
| Lease liabilities | 2,655 | 2,471 | 2,523 |
| Accounts payable | 4,363 | 3,810 | 8,129 |
| Current portion of long-term debt | – | 55,167 | – |
| Other liabilities | 2,033 | 5,523 | 1,633 |
| Accrued expenses and deferred income | 11,345 | 9,004 | 16,975 |
| Total current liabilities | 20,396 | 75,975 | 29,260 |
| Total liabilities | 42,804 | 128,007 | 51,225 |
| Total shareholders' equity and liabilities | 714,934 | 615,798 | 755,952 |
Consolidated statement of changes in equity
Attributable to owners of Mendus AB (publ)
| Retained | |||||
|---|---|---|---|---|---|
| Additional | earnings inc. | ||||
| Share paid in |
profit/loss for | ||||
| Amounts in KSEK | capital | capital | Reserves | the period | Total |
| Opening shareholders' equity 01/01/2024 | 43,157 | 1,394,758 | -5,584 | -727,604 | 704,727 |
| Profit/loss for the period | – | – | – | -35,614 | -35,614 |
| Other comprehensive income | – | – | 2,430 | – | 2,430 |
| Total comprehensive income | – | – | 2,430 | -35,614 | -33,185 |
| Transactions with owners | |||||
| Issued warrants | – | 588 | – | – | 588 |
| Share issue | – | – | – | – | – |
| Costs for new share issue | – | – | – | – | – |
| Total transaction with owners | – | 588 | – | – | 588 |
| Shareholders' equity 31/03/2024 | 43,157 | 1,395,346 | -3,155 | -763,218 | 672,130 |
| 96 3,095 – – 96 3,239 |
– – – |
– – – |
3,191 – 3,335 |
|---|---|---|---|
| – | – | 144 | |
| – | 185 | -30,169 | -29,985 |
| – | 185 | – | 185 |
| – | – | -30,169 | -30,169 |
| 1,130,636 | -181 | -625,985 | 514,440 |
| 9,970 – – – – 144 |
| 33,187 | 264,122 | – | – | 297,309 |
|---|---|---|---|---|
| – | -23,889 | – | – | -23,889 |
| 33,187 | 288,605 | – | – | 321,792 |
| – | -595 | – | – | -595 |
| – | – | -5,403 | -101,619 | -107,022 |
| – | – | -5,403 | – | -5,403 |
| – | – | – | -101,619 | -101,619 |
| 9,970 | 1,130,636 | -181 | -625,985 | 514,440 |
Consolidated statement of cash flows
| 2024 | 2023 | 2023 | ||
|---|---|---|---|---|
| Amounts in KSEK | Note | jan-mar | jan-mar | jan-dec |
| Operating activities | ||||
| Operating profit/loss | -35,317 | -29,609 | -100,650 | |
| Adjustment for items not included in cash flow | 9 | 4,534 | 2,148 | 4,337 |
| Interest income | 1 | – | 2,147 | |
| Interest expense paid | -299 | -171 | -3,115 | |
| Cash flow from operating activities before | ||||
| changes in working capital | -31,081 | -27,632 | -97,281 | |
| Increase/decrease in other current receivables | 8,109 | -510 | -64.337 | |
| Increase/decrease in accounts payable | -2,412 | -3,629 | -729 | |
| Increase/decrease in other current liabilities | -5,231 | -1,783 | -1,831 | |
| Cash flow from operating activities | -30,615 | -33,554 | -162,761 | |
| Investment activities | ||||
| Investments in tangible assets | -1,354 | -492 | -1,823 | |
| Divestments of tangible fixed assets | – | – | 1,387 | |
| Investment in long-term receivables | – | -4 | -7 | |
| Cash flow from investment activities | -1,354 | -495 | -442 | |
| Financing activities | ||||
| New Share issue | – | 3,921 | 321,793 | |
| New share Issue costs | – | – | -23,889 | |
| Repayment of borrowings | -932 | -1,271 | -95,807 | |
| New loans | – | 27,766 | 40,000 | |
| Cash flow from financing activities | -932 | 29,687 | 242,097 | |
| Cash and cash equivalents at the | ||||
| beginning of the period | 120,782 | 41,851 | 41,851 | |
| Cash flow for the period | -32,901 | -4,362 | 78,894 | |
| Foreign echange difference in cash and cash equivalents | 305 | 7 | 37 | |
| Cash and cash equivalents at | ||||
| the end of the period | 88,186 | 37,496 | 120,782 |
FINANCIAL REPORTS PARENT COMPANY
Parent Company income statement
| Amounts in KSEK | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
|---|---|---|---|
| Revenue | – | – | – |
| Other operating income | 1,584 | 1,148 | 6,613 |
| Total revenue | 1,584 | 1,148 | 6,613 |
| OPERATING EXPENSES | |||
| Administration expenses | -6,720 | -8,209 | -25,071 |
| Research and development expenses | -3,848 | -3,133 | -15,208 |
| Other operating expenses | -86 | -171 | -559 |
| Operating profit/loss | -9,069 | -10,365 | -34,225 |
| RESULT FROM FINANCIAL ITEMS | |||
| Financial income | – | – | 2 012 |
| Financial costs | 1 | -244 | -1 589 |
| Profit/loss after financial items | -9,067 | -10,609 | -33,802 |
| TOTAL PROFIT/LOSS BEFORE TAXES | -9,067 | -10,609 | -33,802 |
| Income tax | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -9,067 | -10,609 | -33,802 |
| Earnings/loss per share before and after | |||
| dilution (SEK), for profit attributable to owner | |||
| of the parent company´s shareholders. | -0.01 | -0.05 | -0.07 |
Parent Company statement of comprehensive income
| Amounts in KSEK | 2024 | 2023 | 2023 |
|---|---|---|---|
| jan-mar | jan-mar | jan-dec | |
| Result for the period | -9,067 | -10,609 | -33,802 |
| Other comprehensive income | – | – | – |
| Total comprehensive income for the period | -9,067 | -10,609 | -33,802 |
Parent Company balance sheet
| Amounts in KSEK | 2024-03-31 | 2023-03-31 | 2023-12-31 |
|---|---|---|---|
| ASSETS | |||
| Financial assets | |||
| Participants in Group companies | 900,032 | 731,558 | 889,580 |
| Other long term securities | 1 | – | 1 |
| Other long term receivables | 401 | 394 | 401 |
| Total financial assets | 900,434 | 731,952 | 889,981 |
| Total fixed assets | 900,434 | 731,952 | 889,981 |
| CURRENT ASSETS | |||
| Intercompany receivables | 1,255 | 866 | – |
| Other receivables | 2,844 | 1 058 | 627 |
| Prepaid expenses and accrued income | 935 | 985 | 1,026 |
| Total current receivables | 5,035 | 2,909 | 1,653 |
| Cash and bank balances | 80,200 | 30,357 | 100,427 |
| Total current assets | 85,234 | 33,266 | 102,080 |
| TOTAL ASSETS | 985,669 | 765,218 | 992,061 |
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| Restricted equity | |||
| Share capital | 43,157 | 10,066 | 43,157 |
| Total restricted equity | 43,157 | 10,066 | 43,157 |
| Unrestricted equity | |||
| Share premium reserve | 1,680,534 | 1,418,168 | 1,679,946 |
| Retained earnings | -737,766 | -703,068 | -703,964 |
| Profit/loss for the period | -9,067 | -10,609 | -33,802 |
| Total unrestricted equity | 933,700 | 704,491 | 942,180 |
| Total shareholders' equity | 976,858 | 714,557 | 985,337 |
| LIABILITIES | |||
| LONG-TERM LIABILITIES | |||
| Other long-term liabilities | 850 | 16,275 | 850 |
| Total long-term liabilities | 850 | 16,275 | 850 |
| CURRENT LIABILITIES | |||
| Accounts payable | 1,445 | 1,224 | 1,808 |
| Intercompany liabilities | 3,028 | 4,709 | – |
| Short-term part of long-term liabilities to credit institutions | – | 25,000 | – |
| Other liabilities | 240 | 487 | 564 |
| Accrued expenses and deferred income | 3,248 | 2,966 | 3,502 |
| Total current liabilities | 7,961 | 34,386 | 5,874 |
| Total liabilities | 8,811 | 50,661 | 6,724 |
| Total shareholders' equity and liabilities | 985,669 | 765,218 | 992,061 |
Parent Company statement of changes in equity
| Retained | ||||
|---|---|---|---|---|
| Amounts in KSEK | Share | earnings inc. | ||
| Share | premium | profit/loss for | ||
| capital | reserve | the period | Totalt | |
| Opening shareholders' equity 2024-01-01 | 43,157 | 1,679,946 | -737,766 | 985 338 |
| Profit/loss for the period | – | – | -9,067 | -9,067 |
| Total comprehensive income | – | – | -9,067 | -9,067 |
| Transactions with owners | ||||
| Issued warrants | – | 588 | – | 588 |
| Share issue | – | – | – | – |
| Costs for new share issue | – | – | – | – |
| Total transaction with owners | – | 588 | – | 588 |
| Shareholders' equity 2024-03-31 | 43,157 | 1,680,534 | -746,833 | 976,858 |
| Opening shareholders' equity 2023-01-01 | 9,970 | 1,415,825 | -703,963 | 721,832 |
|---|---|---|---|---|
| Profit/loss for the period | – | – | -10,610 | -10,610 |
| Total comprehensive income | – | – | -10,610 | -10,610 |
| Transactions with owners | ||||
| Issued warrants | – | 144 | – | 144 |
| Share issue | 96 | 3,095 | – | 3,191 |
| Costs for new share issue | – | – | – | – |
| Total transaction with owners | 96 | 3,239 | – | 3,335 |
| Shareholders' equity 2023-03-31 | 10,066 | 1,419,064 | -714,573 | 714,557 |
| Opening shareholders' equity 01/01/2023 | 9,970 | 1,415,825 | -703,963 | 721,832 |
|---|---|---|---|---|
| Profit/loss for the period | – | – | -33,803 | -33,803 |
| Total comprehensive income | – | – | -33,803 | -33,803 |
| Transactions with owners | ||||
| Issued warrants | – | -595 | – | -595 |
| Share issue | 33,187 | 288,605 | – | 321,792 |
| Costs for new share issue | – | -23,889 | – | -23,889 |
| Total transaction with owners | 33,187 | 264,121 | – | 297,308 |
| Shareholders' equity 31/12/2023 | 43,157 | 1,679,946 | -737,766 | 985,338 |
Parent Company cash flow statement
| Amounts in KSEK | Note | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
|---|---|---|---|---|
| Operating activities | ||||
| Operating profit/loss before financial items | -9,067 | -10,609 | -33,802 | |
| Adjustment for items not included in cash flow | 9 | 588 | 144 | -595 |
| Interest income | – | – | 2,012 | |
| Interest expense paid | 1 | -244 | -1,589 | |
| Cash flow from operating activities | ||||
| before changes in working capital | -8,477 | -10,709 | -33,974 | |
| Increase/decrease in accounts receivable | -1,255 | -311 | 1,076 | |
| Increase/decrease in other current receivables | -2,127 | 810 | 681 | |
| Increase/decrease in accounts payable | -363 | 451 | -809 | |
| Increase/decrease in other current liabilities | 2,450 | -1,342 | -3,595 | |
| Cash flow from operating activities | -9,772 | -11,101 | -36,621 | |
| Investment activities | ||||
| Increase/decrease in long term receivable, intra-group | – | 5,318 | – | |
| Investment in financial assets | -10,454 | -20,136 | -178,165 | |
| Cash flow from investment activities | -10,454 | -14,818 | -178,165 | |
| Financing activities | ||||
| New share issues | – | 3,191 | 321,793 | |
| New share issues cost | – | – | -23,889 | |
| Repayment of loans | – | – | -50,000 | |
| New loans | – | 25,000 | 40,000 | |
| Cash flow from financing activities | – | 28,191 | 287,904 | |
| Cash and cash equivalents at the beginning of the period | 100,427 | 27,840 | 27,840 | |
| Cash flow for the period | -20,225 | 2,272 | 73,118 | |
| Foreign echange difference in cash and cash equivalents | -1 | 245 | -531 | |
| Cash and cash equivalents at | ||||
| the end of the period | 80,200 | 30,357 | 100,427 |
Notes
Note 1 – General information
Mendus AB (publ) (hereinafter "Mendus"), 556629-1786 is a Swedish public limited company with its registered office in Stockholm. The address of the company's head office is Västra Trädgårdsgatan 15, SE-111 53 Stockholm, Sweden. On May 16, 2024, the Board of Directors approved this interim report for publication.
Note 2 – Accounting principles
The consolidated financial statements of Mendus have been prepared in accordance with the Swedish Annual Accounts Act, RFR 1 Supplementary Accounting Rules for Groups, as well as International Financial Reporting Standards (IFRS) and interpretations from the IFRS Interpretations Committee (IFRS IC) as adopted by the EU. The consolidated financial statements have been prepared in accordance with the cost method.
The interim report has been prepared in accordance with IAS 34 Interim Financial Reporting and the Annual Accounts Act.
The Parent Company's interim report has been prepared in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board's recommendation RFR 2.
The Group's accounting principles are unchanged and are presented in the Annual Report for 2023 (Note 2, pages 33-35).
In cases where the Parent Company applies accounting principles other than the Group's accounting policies, these are presented in the Annual Report 2023 (Note 2, page 46).
Note 3 – Important estimates and judgments for accounting purposes
The preparation of financial statements requires the use of accounting estimates, which will rarely correspond to actual earnings. Management also makes judgments in the application of the Group's accounting principles. These assessments are unchanged and are presented in the Annual Report for 2023 (Note 5, page 36).
Note 4 – Prospects, significant risks and uncertainty factors
Mendus is a research and development company. The company has not generated any significant revenue historically and is not expected to do so in the near term. The company's product candidates are dependent on research and development and may be delayed and/or incur higher
costs. The company is dependent on its ability to enter into license agreements and joint cooperation agreements, as well as on a large number of approval and compensation systems and related laws, regulations, decisions and practices (which are subject to change). In addition, the company is dependent on intellectual property rights. The risk that is considered to be of particular importance for Mendus' future development is access to sufficient financial resources to support the company's financing needs. The company's Board of Directors and management continuously monitor and evaluate the Group's financial status and the availability of cash and cash equivalents. There is a risk that the available liquidity as of March 31, 2024 will not fund operations beyond the end of 2024 and the company will need to access additional capital to be able to continue to advance the development of the various programs. At the quarter-end, the company has outstanding warrants, which, depending on the outcome, can provide the company with additional liquidity beyond the next 12-month period. It is the Board of Directors' assessment that the company is well placed to secure future financing, but at the time of publication of this report there still exists some uncertainty about the company's ability to fund continued operations.
This report contains forward-looking statements. Actual results may differ from what has been stated. Internal factors such as successful management of research projects and intellectual property rights can affect future performance. There are also external conditions, such as the economic climate, political changes, and competing research projects that can affect Mendus' results.
Note 5 - Information on related party transactions
The parent company Mendus AB is related to the subsidiary Mendus B.V and Mendus Australia Pty. During the first quarter, purchases of goods and services in Mendus AB amounted to KSEK -3,028 (-4,709) and sales amounted to KSEK 1,255 (866). The parent company Mendus AB has also issued a short-term loan to Mendus Australia Pty amounting to KSEK 2,288. No further transactions were made with related parties during the quarter. Transactions with related parties are conducted on market terms.
Note 6 – Financial instruments
Mendus' financial assets and liabilities consist of cash and cash equivalents, other current receivables, other long-term receivables, other long-term securities holdings, other longterm liabilities, other current liabilities and accounts payable. The fair value of all financial instruments is substantially the same as their carrying amounts.
Note 7 - Significant events after end of period
- » Mendus raises approximately SEK 69.1 million through the warrants of series TO3
- » As previously announced, Mendus AB (publ) ("Mendus") carried out a capital raise of units in July 2023 wherein the exercise period for the warrants issued in the capital raise was during April. In total, 144,043,202 warrants were exercised for subscription of 144,043,202 shares in Mendus. As a result thereof, the number of shares and votes in Mendus has changed. The issue of shares subscribed for by way of exercising warrants has resulted in an increase in the number of shares from 863,148,371 shares to 1,007,191,573 shares.
Note 8 – Participations in Group companies
Participations in Group companies refer to shares in Mendus B.V and Mendus Australia Pty. Mendus B.V. was acquired on December 21, 2020 and Mendus AB holds 100% of the capital and voting rights. The number of shares amounts to 60,000,000 shares. Mendus Australia Pty was established on October 9, 2023 and Mendus AB holds 100% of the capital and voting rights. The number of shares amounts to 100.
Note 9 – Adjustments for items not included in cash flow
| Consolidated | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
|---|---|---|---|
| Adjustments for items not including consist of following |
|||
| Depreciation | 1,619 | 1,601 | 6,290 |
| Warrants | 588 | 144 | -595 |
| Translation differences | 2,327 | -389 | -3,202 |
| Accrued interest | – | 16 | – |
| Other, non cash items | – | 776 | 1,844 |
| Total | 4,534 | 2,148 | 4,337 |
| Parent Company | 2024 jan-mar |
2023 jan-mar |
2023 jan-dec |
| Adjustments for items not including | |||
| consist of following | |||
| Depreciation | – | – | |
| – | |||
| Warrants | 588 | 144 | -595 |
| Translation differences Other, non cash items |
– – |
– – |
– – |
| Total | 588 | 144 | -595 |
Key performance measurements
The company presents in this report certain key performance measures, including two measures that is not defined under IFRS, namely expenses relating to research and development/operating expenses and equity ratio. These financial performance measures should not be viewed in isolation or be considered to replace the performance indicators that have been prepared in accordance with IFRS. In addition, such performance measure as the company has defined it should not be compared with other performance measures with similar names used by other companies. This is because the above-mentioned performance measure is not always defined in the same manner, and other companies may calculate them differently to Mendus.
The Group
| 2024 | 2023 | 2023 | ||
|---|---|---|---|---|
| Jan - Mar | Jan - Mar | Jan - Dec | ||
| Share capital at end of period, SEK | 43,157 | 10,066 | 43,157 | |
| Equity at the end of period, KSEK | 672,131 | 487,791 | 704,727 | |
| Earnings per share before and after dilution, SEK | -0.04 | -0.15 | -0.22 | |
| Research and development costs, KSEK | -29,018 | -19,782 | -92,653 | |
| Research and development costs/operating expenses, % | 76% | 66% | 71% |
Parent Company
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| Jan - Mar | Jan - Mar | Jan - Dec | |
| Total registered shares at the beginning of period | 863,148,371 | 199,400,599 | 199,400,599 |
| Total registered shares at the end of period | 863,148,371 | 201,311,406 | 863,148,371 |
| Share capital at end of period, SEK | 43,157 | 10,066 | 43,157 |
| Equity at the end of period, KSEK | 976,858 | 714,557 | 985,337 |
| Earnings per share before and after dilution, SEK | -0.01 | -0.05 | -0.07 |
| Research and development costs, KSEK | -3,848 | -3,133 | -15,208 |
| Research and development costs/operating expenses, % | 36% | 27% | 37% |
Definitions and reconciliation of alternative performance measurements
| Alternative performance | |
|---|---|
| ------------------------- | -- |
| measurementsments | Definition | Justification |
|---|---|---|
| Equity ratio | Total shareholders' equity divided by total assets |
The key ratio provides useful information of the company's capital structure. |
| Research & development costs/operating expenses, % |
Research & development costs/ operating expenses, % |
The research and development /operating expenses ratio is an important complement because it allows for a better evaluation of the company's economic trends and the proportion of its costs that are attributable to the company's core business. |
Derivation The Group
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| Jan - Mar | Jan - Mar | Jan - Dec | |
| Equity ratio at the end of the period % | |||
| Total shareholders equity at the end of the period, KSEK | 672,131 | 487,791 | 704,727 |
| Total assets at the end of the period, KSEK | 714,934 | 615,798 | 755,952 |
| Equity ratio at the end of the period, % | 94% | 79% | 93% |
| Research & Development costs/operating expenses,% | |||
| Research & Development costs | -29,018 | -19,782 | -92,653 |
| Administrative costs | -8,985 | -9,914 | -37,051 |
| Other operating expenses | -98 | -199 | -559 |
| Total operating expenses | -38,101 | -29,896 | -130,263 |
| Research & development costs/operating expenses, % | 76% | 66% | 71% |
Derivation Parent Company
| 2024 | 2023 Jan - Mar |
2023 Jan - Dec |
|
|---|---|---|---|
| Jan - Mar | |||
| Equity ratio at the end of the period % | |||
| Total shareholders equity at the end of the period, KSEK | 976,858 | 714,557 | 985,337 |
| Total assets at the end of the period, KSEK | 985,669 | 765,218 | 992,061 |
| Equity ratio at the end of the period, % | 99% | 93% | 99% |
| Research & Development costs/operating expenses, % | |||
| Research & Development costs | -3,848 | -3,133 | -15,208 |
| Administrative costs | -6,720 | -8,209 | -25,071 |
| Other operating expenses | -86 | -171 | -559 |
| Total operating expenses | -10,653 | -11,513 | -40,838 |
| Research & development costs/operating expenses, % | 36% | 27% | 37% |
Financial Calendar
- » Publication of Quarterly Report, Q2 August 23, 2024
- » Publication of Quarterly Report, Q3 November 8, 2024
- » Publication of Year-end Report 2024 February 13, 2025
For further information, please contact:
Erik Manting, CEO, Mendus
Phone: +46 (0)8 732 8400 E-mail: [email protected]
Lotta Ferm, CFO, Mendus
Telephone: +46 (0)8 732 8400 E-mail: [email protected]
Postal address: Västra Trädgårdsgatan 15 SE- 111 53 Stockholm, Sweden Corporate identity number: 556629-1786
The information contained in this report is that which Mendus (publ), is obliged to publish in accordance with the Swedish Securities Market Act (SFS 2007:528). The information was submitted for publication, through the agency of the contact persons set out above, on May 17, 2024, at 08:00 a.m. CET.
The Group is referred to unless otherwise stated in this Year-end report. Figures in parentheses refer to the corresponding period last year.
This report has been prepared in a Swedish original version and translated into English. In the event of any inconsistency between the two versions, the Swedish language version should have precedence.
www.mendus.com
Head Office Västra Trädgårdsgatan 15 111 53 Stockholm Sweden
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Changing the course of cancer treatment
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