Planegg/Martinsried, April 26,
2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime
Standard), an immuno-oncology platform company focusing on the
discovery and development of T cell immunotherapies for solid
tumors, today reported financial results for the first quarter of
2024. The full Quarterly Statement Q1 2024 can be downloaded here:
https://medigene.com/investors-media/reports-presentations/.
"During the first quarter of 2024, our focus remained on executing
our strategic plan and advancing the development of our unique
TCR-T therapies for solid tumors, such as our lead program
MDG1015," said Selwyn Ho, CEO at Medigene. "While our core
expertise lies in generating optimal TCRs, we are also exploring
ways to broaden their application beyond TCR-T cell therapies."
"The recently announced capital increase will
bolster our financial position," Selwyn Ho continued. "This will
enable us to continue to advance our TCR-T therapies as well as
pursue new partnerships and expand our End-to-End Platform into
TCR-based therapies like T cell engagers (TCE) and TCR-Natural
Killer (TCR-NK) therapies. By expanding our platform, we aim to
create added value for both patients with solid tumors and our
shareholders."
Financial and corporate development
The financial performance in Q1 2024 was in line
with the Executive Management Board’s
expectations. Revenues amounted to EUR 3.0 million
during the first quarter of 2024, derived from partnerships.
R&D expenses for the quarter amounted to EUR 3.2 million,
demonstrating the Company’s continued dedication to advancing its
pipeline. As of March 31, 2024, the Company holds cash and cash
equivalents in the amount of EUR 4.4 million and time deposits of
EUR 8.0 million.
The Management Board therefore maintains its
guidance for fiscal year 2024 published in the annual report 2023
on March 28, 2024, in its entirety, and confirms its cash runway
into April 2025.
From a partnering perspective, the Company’s
ongoing global strategic collaboration with BioNTech continues to
make good progress and Medigene is working on a number of
undisclosed targets. In January 2024, Regeneron Pharmaceuticals
Inc. (Regeneron; formerly: 2seventy bio, Inc.) commenced patient
enrollment in an investigator-initiated trial (IIT) in Greater
China for the program utilizing Medigene's TCR targeting MAGE-A4.
Upon reaching the contractually agreed milestone for the IIT,
Medigene anticipates receiving an additional milestone payment. As
previously announced, Medigene and Hongsheng Sciences have mutually
agreed to terminate the remaining framework agreement of the
partnership. Those assets previously under this agreement have been
returned to Medigene for potential expansion of its pipeline.
Subsequent to the quarter, on April 23, 2024,
the Company announced the launch of a capital raise with
subscription rights as part of the Company’s near and medium-term
financing strategy. Medigene intends to use the gross proceeds of
up to approximately EUR 5.9 million to fund its operating
activities and to progress work for the clinical development of the
Company’s lead program, MDG1015.
Members of Medigene AG’s management and
Supervisory Board will subscribe for new shares as part of the
rights offering and the private placement. Within the framework of
a backstop agreement, an investor has declared his commitment to
Medigene to acquire unsubscribed new shares in an amount of up to
EUR 3 million.
The parameters of the capital increase are as
follows: The Company plans to increase its share capital from EUR
24,562,658.00 by up to EUR 4,912,531.00 to up to EUR 29,475,189.00
by issuing up to 4,912,531 new no-par value registered shares with
a pro rata amount of the share capital of EUR 1.00 and with full
dividend rights from January 1, 2023.
The new shares will be offered to all
shareholders for subscription. Over-subscription is permitted. Any
unsubscribed new shares will be offered for purchase in a private
placement to new investors within the European Union. The
subscription ratio is set at 5:1, i.e. five (5) old shares entitle
the subscription to one (1) new share. Organized trading of
subscription rights is arranged. The subscription price for both
the exercise of subscription rights and the private placement is
EUR 1.20. The subscription period for the new shares commenced on
April 24, 2024 and ends on May 7, 2024 at 24:00 hours (CEST). The
new shares are to be admitted to trading on the Frankfurt Stock
Exchange (Prime Standard) after they are issued. The capital
increase will not require a prospectus. Details of the rights
offering are published in the Federal Gazette also are available on
the Company’s website
https://medigene.com/investors-media/stock-information/capital-measures/
Scientific and clinical development
In February 2024, Medigene announced the initial
clinical indications for the first-in-human Phase 1 clinical trial
for its lead program MDG1015, selecting gastric cancer, ovarian
cancer, myxoid/round cell liposarcoma and synovial sarcoma as the
target cancers to be treated. Following recent positive EU and US
preliminary regulatory interactions, the program remains on track
for an IND/CTA approval in the second half of 2024. Subject to
financing, the Company expects to initiate a Phase 1 trial for
MDG1015 by the end of 2024.
In April 2024, the Company presented data for
MDG1015 at the American Association for Cancer Research (AACR)
Annual Meeting, which showed superior T cell functionality and
tumor cell killing as well as a favorable safety profile of TCR-T
cells armored and enhanced with Medigene’s PD1-41BB costimulatory
switch protein. The poster data further illustrated that this
costimulatory switch protein-mediated costimulatory signal is
TCR-gated, indicating that costimulation only occurs when the TCR
binds to the tumor antigen present on a tumor cell. As such,
healthy cells that did not express the tumor antigen (NY-ESO-1)
were not targeted, irrespective of their PD-L1 expression and no
signs of toxicity were seen in diverse healthy tissues in
vitro.
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About Medigene AG
Medigene AG (FSE: MDG1) is an immuno-oncology
platform company dedicated to developing differentiated T cell
therapies for treatment of solid tumors. Its End-to-End Platform is
built on multiple proprietary and exclusive technologies that
enable the Company to generate optimal T cell receptors against
both cancer testis antigens and neoantigens, armor and enhance
these T cell receptor engineered (TCR) -T cells to create
best-in-class, differentiated TCR-T therapies, and optimize the
drug product composition for safety, efficacy and durability. The
End-to-End Platform provides product candidates for both its own
therapeutics pipeline and partnering. Medigene’s lead TCR-T program
MDG1015 is expected to receive IND/CTA approval in the second half
of 2024. For more information, please visit
https://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.
Medigene AG
Pamela Keck Phone: +49 89 2000 3333 01 E-mail:
investor@medigene.com
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