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-19Affimed 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 UpdatesAffimed 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 ProductAt 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, 2020Affimed 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 STATEMENTSThis 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 ContactsGregory Gin, Head of Investor Relations
E-Mail: [email protected]
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