Affimed N.V.: Affimed Reports Second Quarter 2020 Financial Results and Operational Progress

-- Continued progress in the AFM13 pTCL REDIRECT monotherapy study 
 
   -- AFM24 is recruiting patients in cohort 2 of a Phase 1/2a clinical trial 
 
   -- Genentech's RO7297089 is actively recruiting patients into a 
      first-in-human Phase I trial resulting in the achievement of a milestone 
      payment under the terms of the collaboration 
 
   -- Data on AFM24 and RO7297089 (formerly AFM26) were presented at the 
      virtual AACR II conference in June 
 
   -- Angus Smith joins the company as Chief Financial Officer 
 
   -- Dr. Annalisa Jenkins and Harry Welten added to the Supervisory Board 
 
   -- EUR92.6 million of cash, cash equivalents and current financial assets as 
      of June 30, 2020, providing anticipated cash runway into the first half 
      of 2022 
 
   -- Conference call and webcast scheduled for August 11, 2020 at 8:30 am EDT 
      (14:30 CET) 
 
 
   Heidelberg, Germany, August 11, 2020 -- Affimed N.V. (Nasdaq: AFMD), a 
clinical-stage immuno-oncology company committed to giving patients back 
their innate ability to fight cancer, today reported financial results 
for the second quarter 2020 and provided an update on clinical and 
corporate progress. 
 
   "Affimed's first half performance demonstrates the strength of the new 
management team and our ability to stay focused on executing our 
business strategy despite the continuing challenge of the COVID-19 
environment. Always with the patient in mind, we are committed to 
advancing our pipeline as well as continuing to deepen our research to 
unlock the full potential of the innate immune system to fight cancer," 
said Dr. Adi Hoess, CEO of Affimed. "We have multiple Innate Cell 
Engager (ICE(R)) programs in clinical development, both partnered and 
wholly-owned, which are the basis for providing a cadence of a 
continuous data output in 2020 and 2021." 
 
   Development Program Updates 
 
   AFM13 (CD30/CD16A) 
 
 
   -- Affimed has now successfully activated 54 clinical study sites in 10 
      countries in the on-going Phase 2 registration-directed study of AFM13 as 
      monotherapy in relapsed or refractory patients with CD30-positive 
      peripheral T-cell lymphoma (pTCL).  The study follows a two-stage Simon 
      design with a preplanned interim analysis after 40 patients. At the 
      current recruitment rate the company expects the readout of the interim 
      analysis to happen in mid-2021. 
 
   -- The investigator-sponsored Phase 1 study with the University of Texas, MD 
      Anderson Cancer Center (MDACC), which investigates the combination of 
      AFM13 with allogeneic NK cells in CD30+ Lymphomas, has completed the 
      required validation work in order to administer a stable complex of AFM13 
      pre-mixed with cord blood-derived allogeneic NK cells. MDACC has recently 
      posted this study as enrolling on its website and it is expected to 
      recruit patients as soon as the COVID-19 conditions in Texas permit. 
 
 
   AFM24 (EGFR/CD16A) 
 
 
   -- AFM24-101, a first-in-human Phase 1/2a clinical trial of AFM24, the 
      EGFR/CD16A targeted innate cell engager for relapsed/ refractory patients 
      with advanced EGFR-expressing solid tumors continues to recruit according 
      to plan in cohort 2. 
 
   -- AFM24-101 is an open-label, non-randomized, multi-center, multiple 
      ascending dose escalation/expansion study to evaluate AFM24 as 
      monotherapy in adult patients with advanced solid malignancies known to 
      be EGFR-positive. 
 
   -- No dose limiting toxicity was observed in dose cohort 1. 
 
   -- A preclinical poster presentation was shown at the virtual AACR II 
      conference in June on AFM24, demonstrating that it is differentiated from 
      all other EGFR targeting entities: (i) it appears safe - no skin toxicity 
      or other dose limiting toxicities (DLTs) in cynomolgus monkeys, (ii) it 
      addresses a broad patient population -- AFM24 targets EGFR independent of 
      its mutational status, and (iii) in contrast to monoclonal antibodies, 
      AFM24 strongly activates NK cells and macrophages. 
 
 
   Genentech Collaboration Update 
 
 
   -- The Genentech-partnered, novel BCMA-targeted innate cell engager for the 
      treatment of multiple myeloma has now entered a first-in-human Phase I, 
      open-label, multicenter, global dose-escalation study designed to 
      evaluate the safety, tolerability, and pharmacokinetics of RO7297089. The 
      milestone was achieved in the third quarter and triggers a payment in an 
      undisclosed amount to Affimed, which is expected to be recognized in the 
      Company's third quarter 2020 financial statements. 
 
   -- At the June virtual AACR II conference, a preclinical poster presentation 
      on RO7297089 showed potent cell killing in tumor cell lines employing NK 
      cells as effector cells with minimal increase in cytokines.  A 4-week 
      safety study in cynomolgus monkeys showed a favorable safety profile with 
      no cytokine release or adverse findings at the 15 and 50 mg/kg tested 
      dose levels. Furthermore, time- and dose-dependent reductions in serum 
      IgG levels and plasma cell markers were observed suggesting selective 
      killing of BCMA positive cells by engaging CD16a positive immune cells. 
 
 
   Preclinical Pipeline Update 
 
 
   -- Progress continues on AFM28 and AFM32 towards late stage preclinical 
      development. 
 
 
 
 
   Management Appointments 
 
 
   -- Angus Smith joined the company as Chief Financial Officer on July 13. Mr. 
      Smith brings broad biopharmaceutical experience to the company including 
      financial strategy and planning, capital markets, business development 
      and operations. Mr. Smith's appointment completes the planned additions 
      to the management team which now includes Dr. Andreas Harstrick, Chief 
      Medical Officer and Dr. Arndt Schottelius, Chief Scientific Officer. 
 
 
   Additions to the Supervisory Board 
 
 
   -- Dr. Annalisa Jenkins and Harry Welten were appointed to the Supervisory 
      Board during the recent Annual General Meeting of Shareholders. Dr. 
      Jenkins brings a wealth of expertise in advancing clinical programs 
      through development and regulatory approval. Mr. Welten is an 
      accomplished financial executive who is well suited to help drive 
      value-creating strategies for the company. These additions to the 
      Supervisory Board are expected to further strengthen the company's 
      industry know-how, experience and diversity. 
 
 
   Second Quarter 2020 Financial Highlights 
 
   (Figures for the second quarter ended June 30, 2020 and 2019 are 
unaudited.) 
 
   As of June 30, 2020, cash, cash equivalents and current financial assets 
totaled EUR92.6 million compared to EUR104.1 million on December 31, 
2019. During the quarter, the company received net proceeds of 
approximately EUR20.8 million under its at-the-market ("ATM") program. 
 
   Based on its current operating plan and assumptions, Affimed anticipates 
that its cash, cash equivalents and current financial assets will 
support operations into the first half of 2022. 
 
   Net cash used in operating activities for the quarter ended June 30, 
2020 was EUR15.0 million compared to EUR5.6 million in the second 
quarter of 2019. The second quarter 2019 net cash used in operating 
activities included a milestone payment to the company from the 
Genentech collaboration. 
 
   Total revenue for the second quarter of 2020 was EUR2.9 million compared 
with EUR4.0 million in the second quarter of 2019. Revenue in 2020 and 
2019 predominantly relate to the Genentech collaboration (2020: EUR2.7 
million, 2019: EUR3.7 million). Revenue from the Genentech collaboration 
in the second quarter 2020 was comprised of revenue recognized for 
collaborative research services performed during the quarter. 
 
   R&D expenses for the second quarter of 2020 were EUR11.7 million 
compared to EUR11.5 million in the second quarter of 2019. Expenses in 
2020 relate predominantly to our AFM13 and AFM24 clinical programs as 
well as to our early stage development and discovery activities. 
 
   G&A expenses for the second quarter of 2020 were EUR2.6 million compared 
to EUR2.3 million in the second quarter of 2019. The increase is 
primarily related to higher Sarbanes-Oxley compliance costs, as well as 
an increase in legal, consulting and audit costs. 
 
   Net loss for the second quarter of 2020 was EUR12.2 million or EUR0.16 
per common share. For the second quarter of 2019, the company's net loss 
was EUR10.3 million or EUR0.17 per common share. 
 
   Weighted number of common shares outstanding for the quarter ended June 
30, 2020 were 79.2 million. 
 
   Affimed encourages shareholders to also review its 6-K filing for the 
quarter ended June 30, 2020, as filed with the United States Securities 
and Exchange Commission. 
 
   Note on International Financial Reporting Standards (IFRS) 
 
   Affimed prepares and reports consolidated financial statements and 
financial information in accordance with IFRS as issued by the 
International Accounting Standards Board. None of the financial 
statements were prepared in accordance with Generally Accepted 
Accounting Principles in the United States. Affimed maintains its books 
and records in Euro. 
 
   Conference Call and Webcast Information 
 
   Affimed will host a conference call and webcast today, Tuesday, August 
11, 2020 at 8:30 a.m. EDT to discuss second quarter 2020 financial 
results and recent corporate developments. The conference call will be 
available via phone and webcast. 
 
   To access the call, please dial [phone] for U.S. callers, or 
[phone] for international callers, and reference passcode 
8855368 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 

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August 11, 2020 06:30 ET (10:30 GMT)