“In the second quarter of 2023, Mendus’ main objectives were focused on driving the evolution of our pipeline and securing the related financing. The progress made in the previous quarters, including the positive survival data of the ADVANCE II trial, improvements of our production processes and adjusting our strategy to the rapidly evolving cancer therapy landscape, provided the basis for a next financing round, which we announced last June. The directed placement and rights issue totaling approximately SEK 317M will support the ongoing ADVANCE II and ALISON vididencel trials, the start of a combination trial with vididencel in AML maintenance and the start of a new clinical trial with ilixadencel in soft tissue sarcomas. The new financing will furthermore be used for the development of our preclinical NK cell program and the recently announced manufacturing alliance with NorthX Biologics.
Mendus is committed to changing the course of cancer treatment by positioning our product candidates where they can have the biggest impact on survival, combined with a benign safety profile. This is particularly relevant for cancer maintenance therapy, which aims to extend disease-free survival following initial treatment. Our lead program vididencel is currently studied in the ADVANCE II monotherapy Phase 2 trial as a maintenance therapy for acute myeloid leukemia (AML). Following the positive survival data reported at the end of 2022, we prepare for a next read-out of the ADVANCE II trial in the fourth quarter of 2023. In the meantime, we carry out the in-depth analysis of the study samples collected as part of the trial. These immunomonitoring data provide useful insights in the interaction between vididencel and the immune system. Immunological analyses of patient samples before and after vididencel treatment support vididencel’s mode of action as an immunotherapy which boosts antitumor responses against residual disease and were presented at the CIMT and EHA conferences during the second quarter.
Based on the monotherapy efficacy data and excellent safety profile reported in the ADVANCE II trial, combined with supportive preclinical data, an obvious next step is to combine vididencel with oral azacitidine, currently the only approved drug for AML maintenance. This new combination trial is expected to start before the year-end of 2023. The trial with oral azacitidine will be important to study this combination in the clinical setting and as a step-up towards pivotal-stage development. In parallel, Mendus will set up the large-scale manufacturing of vididencel required for late-stage clinical development and commercialization. For this, Mendus has closed a manufacturing alliance with NorthX Biologics, a leading Swedish contract development and manufacturing organization for cell and gene therapies. This alliance will provide stability for our manufacturing plans and bring additional resources and competence. NorthX Biologics will be a significant partner going forward.
Initial data from the Phase 1 ALISON trial studying vididencel as a maintenance therapy in ovarian cancer were presented at the American Association for Cancer Research (AACR) conference held in April 2023. The data confirmed the benign safety profile and potential of vididencel to stimulate immune responses against tumor antigens previously shown to be relevant for ovarian cancer. Based on the positive data, recruitment of the ALISON trial will continue, and additional read-outs of the trial are expected in the coming months.
Following a series of manufacturing process improvements, Mendus’ second clinical-stage program ilixadencel is ready to be tested in a proof-of-concept trial based on initial positive data observed in gastrointestinal stromal tumors (GIST). There continues to be clinical interest in pursuing a trial in soft-tissue sarcomas, of which GIST is a subtype. We will choose the exact indication based on medical need and competition from other drugs in development and expect a next trial to commence before year-end 2023.
Mendus has earmarked the application of its proprietary DCOne platform to expand natural killer (NK) cells for therapeutic purposes as the main focus of its preclinical research activities. We particularly focus on memory NK cells, which are associated with improved persistence, metabolic fitness and tumor cell killing capacity and reduced relapse rates in blood-borne tumors. We were happy to announce during the second quarter the appointment of NK cell pioneer Lewis Lanier to our Scientific Advisory Board.
Concluding, the first half of 2023 has provided the basis for the next phase of corporate development for Mendus. With two programs moving forward in the clinic on a solid basis and a promising preclinical pipeline, the Company is positioned stronger than ever before to address key challenges in today’s cancer treatment.”
Erik Manting, Ph.D.
Chief Executive Officer
SIGNIFICANT EVENTS IN Q2 2023
- Mendus held an investor update call following the Annual Report publication on April 17, 2023
- Mendus receives ATMP certificate from European Medicines Agency supporting its lead pipeline program vididencel
- Mendus presents comprehensive ADVANCE II immunomonitoring data at the EHA Annual Meeting 2023
- Mendus presented updated clinical data from ADVANCE II trial in an oral presentation and a scientific poster on a next-generation immune primer program at the 2023 CIMT Annual Meeting
- Mendus presented positive data from the ALISON trial in ovarian cancer at the AACR Annual Meeting 2023
- Mendus appoints NK cell pioneer Lewis Lanier to Scientific Advisory Board
- Mendus reports outcome from the Annual General Meeting on May 12, 2023
- Mendus redeemed the outstanding convertible bonds from Negma Group
- Mendus secures third shareholder loan from Van Herk Investments
- Mendus announces a directed share issue and a fully secured rights issue of units totaling approximately SEK 317 million in financing
- Mendus and NorthX Biologics to enter into strategic cell therapy manufacturing alliance supported by new investor Flerie
- Mendus’ provides update and outlook on vididencel program in online and on-site events on June 27, 2023
SIGNIFICANT EVENTS AFTER END OF REPORTING PERIOD
- Mendus reports outcome from the Extraordinary General Meeting on July 10, 2023
- Mendus publishes prospectus regarding previously announced rights issue and directed issue
- Mendus reports outcome of previously announced rights issue and directed issue
FINANCIAL SUMMARY
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Full Year | |
| KSEK unless otherwise stated | 2023 | 2022 | 2023 | 2022 | 2022 |
| Net sales | - | - | - | - | - |
| Operating profit/loss | -27,737 | -28,133 | -57,346 | -54,953 | -133,957 |
| Net profit/loss | -3,886 | -29,318 | -34,054 | -56,900 | -138,786 |
| Earnings/loss per share, before and after dilution (SEK) | -0.02 | -0.15 | -0.17 | -0.29 | -0.70 |
| Cash | 20,186 | 84,855 | 20,186 | 84,855 | 41,850 |
| Shareholders’ equity | 485,171 | 600,339 | 485,171 | 600,339 | 514,439 |
| Number of employees at the end of the period | 30 | 32 | 30 | 32 | 31 |
The Q2 2023 report is available on: https://mendus.com/investors/financial-reports/
ABOUT MENDUS AB (PUBL)
Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/
FOR MORE INFORMATION, PLEASE CONTACT:
Erik Manting
Chief Executive Officer
E-mail: ir@mendus.com
INVESTOR RELATIONS
Corey Davis
LifeSci Advisors, LLC
Telephone: + 1 212-915-2577
E-mail: cdavis@lifesciadvisors.com
MEDIA RELATIONS
Mario Brkulj
Valency Communications
Telephone: +49 160 9352 9951
E-mail: mbrkulj@valencycomms.eu
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