Affimed Provides COVID-19-Related Business Update and Announces Full Year 2019 Financial Results Conference Call on April 28,...
April 02 2020 - 06:30AM
Heidelberg, Germany, April 2, 2020
– Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, today provided an update on its
operations in response to the continued spread of the COVID-19
coronavirus pandemic. Affimed also announced that it will host a
conference call on Tuesday, April 28, 2020 at 8:30 a.m. ET to
discuss its full year 2019 financial results and recent corporate
developments.
“Our priority at this time is to ensure the
safety and health of our employees, their families, our partners
and the patients we serve, while also maintaining continuity of our
business and ongoing clinical trials,” said Dr. Adi Hoess,
Affimed’s CEO. “The unprecedented and expanding COVID-19 global
health crisis will require an extraordinary amount of healthcare
resources that we expect will have an impact on our clinical
trials. As circumstances around the COVID-19 pandemic continue to
rapidly evolve, we are continuously assessing possible effects on
our clinical trials and adapting the risk mitigation measures we
have implemented to date, and will update trial timelines after we
have more visibility on the length and extent of the COVID-19
crisis.”
Affimed’s Response to COVID-19
- Affimed is closely monitoring and adhering to federal and local
guidelines on COVID-19 in the U.S. and Germany to ensure the safety
and health of its global workforce and help limit the spread of
COVID-19, while maintaining business continuity. The company
mandated a work-from-home policy for all employees not involved in
preclinical research, and adjusted operations for laboratory
personnel at Affimed’s headquarters in Heidelberg, Germany. In
addition, the company eliminated nonessential travel to minimize
exposure to COVID-19.
- The company will continue to work closely with clinical sites
as well as respective competent authorities to ensure the safety of
trial participants and healthcare professionals, as well as the
appropriate use of healthcare resources during the COVID-19
pandemic, while preserving the conduct and data integrity of its
clinical studies.
- Due to the company’s ongoing assessment of the potential impact
of the COVID-19 pandemic on patient enrollment and site activation
in its clinical studies and the rapidly evolving nature of the
global health crisis, Affimed will update trial timelines after it
has more visibility on the length and extent of the COVID-19
crisis.
- The company has taken mitigation steps to ensure that drug
supply and other trial-related materials are ready and available
for the patients enrolled in its clinical trials.
Development Program Updates
- Affimed has successfully activated 39 clinical study sites for
its ongoing Phase 2 registration-directed study of AFM13 as a
monotherapy in relapsed or refractory patients with CD30-positive
peripheral T cell lymphoma (pTCL).
- The University of Southern California (USC) Norris
Comprehensive Cancer Center was activated as the first clinical
research site and has initiated patient screening in Affimed’s
Phase 1/2a clinical study. The study is aimed at establishing
safety and identifying initial signals of efficacy of AFM24, the
tetravalent, bispecific epidermal growth factor receptor (EGFR)-
and CD16A-binding innate cell engager, in patients with advanced
cancers known to express EGFR.
- Preclinical research for ongoing internal and partnered
programs under the company’s collaboration with Genentech remains
unimpacted by the COVID-19 pandemic at this time.
Manufacturing and Supply of Clinical Drug
Product
- At this time, the company’s contract manufacturers are
operating without interruption, and there is sufficient material
for the AFM13 Phase 2 registration-directed study in pTCL, the
investigator sponsored trial of cord blood-derived allogeneic
natural killer (NK) cells in combination with AFM13, and the AFM24
Phase 1/2a clinical study. Additionally, the company currently does
not foresee any interruption in its ability to continue to
manufacture additional product to be used beyond the current
ongoing clinical studies.
Full Year 2019 Financial Results Conference Call on
April 28, 2020
Affimed will host a conference call and webcast
on Tuesday, April 28, 2020 at 8:30 a.m. Eastern time to discuss the
company’s full year 2019 financial results and recent corporate
developments. The conference call will be available via phone and
webcast. To access the call, please dial +1 (877) 870-9135 for U.S.
callers, or +44 (0) 2071 928338 for international callers, and
reference passcode 7978047 approximately 15 minutes prior to the
call.
A live audio webcast of the conference call will
be available in the “Webcasts” section on the “Investors” page of
the Affimed website at
https://www.affimed.com/investors/webcasts_cp/, and a replay of the
webcast will be accessible at the same link for 30 days following
the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer. Affimed’s fit-for-purpose ROCK®
platform allows innate cell engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat hematologic and solid tumors. For
more information, please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” and similar
expressions. Forward-looking statements appear in a number of
places throughout this release and include statements regarding our
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the value of our ROCK®
platform, our ongoing and planned preclinical development and
clinical trials, our collaborations and development of our products
in combination with other therapies, the timing of and our ability
to make regulatory filings and obtain and maintain regulatory
approvals for our product candidates, our intellectual property
position, our collaboration activities, our ability to develop
commercial functions, clinical trial data, our results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
we operate, the trends that may affect the industry or us, impacts
of the COVID-19 pandemic and the risks, uncertainties and other
factors described under the heading “Risk Factors” in Affimed’s
filings with the Securities and Exchange Commission. Given these
risks, uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no
obligation to update these forward-looking statements, even if new
information becomes available in the future.
Affimed Investor and Media
Contacts
Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
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