Planegg/Martinsried (pta006/12.11.2020/07:30) - Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today provides an update on Q3 2020 and confirms the financial guidance released on 22 September 2020. The full version of the Quarterly Statement Q3 2020 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/
Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene:
"The COVID-19 pandemic represents an ongoing challenge on many fronts but Medigene continues to operate without any significant pandemic-related disruption with the health and safety of employees and patients as a priority. Our MDG1011 clinical trial in Germany continues to see patients with dosing of the third dose cohort expected to be completed in Q1 next year. The MDG1021 clinical trial in the Netherlands was successfully initiated. However, delays in patient recruitment associated with the growing incidence of COVID-19 cannot be ruled out.
Towards the end of September we introduced measures within the company to extend our cash runway into Q3 2022.These difficult measures resulted in a significant reduction in our personnel and third-party expenses as well as an even greater focus in our preclinical research activities on developing enhanced T cell receptor-modified T cell therapies (TCR-T) for the treatment of solid tumors. We have recently presented some of the key elements of this pre-clinical work at the SITC 2020 virtual conference and will continue to raise the profile of our work at future conferences.
I would like to take the opportunity to again thank all our employees and partners for their efforts to develop Medigene's technologies to bring innovative new immunotherapies to cancer patients."
Axel Sven Malkomes, Chief Financial Officer and Chief Business Officer at Medigene: "Medigene's continued progress in developing its technologies with finite financial resources and in challenging times reflects the tremendous efforts of the teams involved. Our drive is to maintain momentum on key programs while tightly controlling costs and enabling an adequate cash runway. Additionally, the continuous evaluation of new partnering opportunities related to our portfolio of technologies and product candidates position Medigene to build further value which we hope to see more fully recognized by the markets in the future."
Business review Q3 2020 and outlook
* Medigene has decided to concentrate all future preclinical research and development activities on developing functionally enhanced TCR-T cells as treatments for solid tumors (MDG10XX), the most significant commercial opportunities for Medigene's clearly differentiated technologies.
As part of this strategic focus, cost-saving measures are being implemented including a reduction of costs for external services as well as of the number of employees across all departments by the end of 2020. These measures will reduce the cash burn and secure the Company's financing into Q3 2022.
* Medigene continues the research and development work on its various approaches such as the PD1-41BB switch receptor or tumor-specific antigens (TSAs) from the Université de Montréal and IRICoR collaboration as innovative tools to enhance the safety and activity of TCR-T therapies with the objective of advancing Medigene's technology towards solid tumor indications. The progress of these preclinical projects is currently not affected by the COVID-19 pandemic.
* Patient recruitment and treatment in the Phase I/II clinical trial of MDG1011 against blood cancers continues steadily, completion of dosing of the third dose cohort in the Phase I part is expected in Q1 2021.
* The Phase I clinical trial of MDG1021 in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation was started at the Leiden University Medical Center (LUMC), the Netherlands. Despite the ongoing COVID-19 pandemic, the LUMC continues to actively screen patients with the intention to begin treatments as soon as possible. However, delays in patient recruitment due to the COVID-19 pandemic cannot be completely ruled out.
* Positive feasibility results of the completed Phase I/II DC vaccine clinical trial in patients with acute myeloid leukemia were presented at the SITC 2020 virtual conference and final results will be presented at the virtual ASH Annual Meeting and Exposition in December 2020. Medigene's partner Cytovant Sciences HK Limited (Roivant/Cytovant) will continue the development of the DC vaccine as "CVT-DC-01" in its licensed territories in Asia. Medigene is pursuing further partnerships for other regions .
* In October 2020, Medigene concluded a further service agreement with Roivant/Cytovant to support process development activities for the manufacturing of the DC vaccines.
* In November 2020, Medigene and bluebird bio, Inc. presented preclinical data on the MAGE-A4-specific TCR at the virtual SITC 2020 conference and Medigene's preclinical activities under the partnership are continuing undisrupted by the ongoing COVID-19 pandemic.
Financial development and guidance
Total revenues in Q3 2020 increased by Eur885 k from Eur1,303 k for Q3 2019 to Eur2,188 k. This is mainly due to the TCR Discovery Agreement with Roivant/Cytovant, which became effective in April 2020.
Research and development expenses of Eur5,932 k in Q3 2020 were Eur392 k higher than in the same period of the previous year (Q3 2019: Eur5,540 k), mainly due to the expansion of the development pipeline and the ongoing costs for the execution of clinical studies and preclinical activities of Medigene.
As a result, earnings before interest, taxes, depreciation and amortization (EBITDA) were Eur194 k higher than in the previous year (Q3 2019: Eur-5,394 k) and amounted to Eur-5,200 k in Q3 2020.
As of 30 September 2020, cash and cash equivalents and time deposits amounted to Eur35,798 k (31 December 2019: Eur54,682 k). The main reason for the decrease in cash and cash equivalents and fixed-term deposits in the first nine months of 2020 is research and development spending to advance Medigene's expanded clinical and preclinical activities.
Currently, Medigene does not expect the COVID-19 pandemic to have a material impact on total revenues, research and development costs and EBITDA loss and confirms its financial guidance for 2020 as revised on 22 September 2020, which reflects the Company's focus and progress in its core immunotherapeutic business. The Company continues to expect total revenues of Eur7-9 m, research and development costs of Eur22-26 m and an EBITDA loss of Eur17-24 m in 2020.
Based on current planning and in view of the cost saving measures taken, the company is financed into Q3 2022.
Medigene will not hold a telephone conference regarding the Quarterly Statement Q3 2020 but we remain available in the usual way for all enquiries.
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Medigene AG (FSE: MDG1, Prime Standard, ISIN DE000A1X3W00) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.
For more information, please visit www.medigene.com
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.
Dr. Gary Waanders, Dr. Anna Niedl
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