- Established strategic collaboration agreement with Genentech for NK cell engager-based
immunotherapeutics: Received $96 million in upfront and committed funding, may be eligible to
receive up to additional $5 billion over time, including payments upon achievement of specified
development, regulatory and commercial milestones, plus royalties on sales
- Six presentations highlighting Affimed’s innate immunity and T cell-based therapeutic programs
will be presented at the 60th American Society of Hematology (ASH) Annual Meeting
- Updated data showed combination of AFM13 and Keytruda® (pembrolizumab) achieved a 39%
complete response rate and 87% objective response rate in patients with relapsed/refractory
- Updated data for AFM13 monotherapy showed a 50% objective response rate in patients with
relapsed/refractory CD30+ lymphoma with cutaneous lesions_
- Company to host investor meeting on Friday, December 7, to review clinical development
strategy for AFM13
Heidelberg, Germany, November 7, 2018 – Affimed N.V. (Nasdaq: AFMD), a clinical stage
biopharmaceutical company focused on discovering and developing highly targeted cancer
immunotherapies that harness the power of innate and adaptive immunity (NK cells,
macrophages and T cells), today reported financial and operational results for the quarter ended
September 30, 2018.
“Our progress in the third quarter is highlighted by the exciting strategic collaboration that we
entered into with Genentech based on our proprietary ROCK® platform,” said Dr. Adi Hoess,
Affimed’s CEO. “This partnership is a transformational accomplishment for Affimed, and is based on both our technology platform and expertise in innate immunity. Separately, at the 2018 ASH Annual Meeting, we look forward to sharing updated clinical data of AFM13 showing continued
promising signs of therapeutic efficacy both in combination with Keytruda® in Hodgkin lymphoma
and as monotherapy in CD30-positive lymphoma. We are working toward finalizing our plans for
a registrational clinical study for AFM13 and will provide an update in early December."
Investor Meeting on Friday, December 7, 2018
- Affimed will host a meeting with the investment community to review the clinical
development strategy for AFM13 on Friday, December 7, 2018 in New York City. Topics
will include future planned clinical activities for AFM13 as monotherapy treatment and in
rational combinations. Further details will be announced closer to the date of the meeting.
Collaboration Agreement with Genentech
- During the quarter, Affimed entered into a strategic collaboration agreement with
Genentech, a member of the Roche Group, to develop and commercialize novel NK cell
engager-based immunotherapeutics based on Affimed’s proprietary Redirected Optimized
Cell Killing (ROCK®) platform to treat multiple cancers. On October 31, 2018, Affimed
received $96 million in upfront and committed funding, and may be eligible to receive up
to an additional $5 billion including payments on achievement of certain development,
regulatory and commercial milestones, plus royalties on sales.
Third Quarter and Recent Pipeline Progress
CD16A innate immune cell engager programs
- Data from Phase 1b Combination Study of AFM13 with Merck’s Keytruda®
(pembrolizumab) to be Presented at 2018 ASH. Affimed will present data on all 30
patients (pts) administered the combination of AFM13 with pembrolizumab at the 60th
American Society of Hematology (ASH) Annual Meeting. Key clinical outcomes, including
objective response rate (ORR) and complete response (CR) rate will be released. An ASH
abstract released on November 1, 2018 highlighted early data that showed an 87% ORR
and a 39% CR rate in 23 evaluable pts from the highest dose cohort as of a June 29, 2018
data cut-off. Updated data for all pts (24 pts from the highest dose cohort plus 6 pts treated
at lower doses) will be presented at ASH.
- Clinical and Biological Evaluation of AFM13 as Monotherapy in Relapsed or Refractory
CD30-Positive Lymphoma to be Presented at 2018 ASH. A poster presentation by Ahmed
Sawas, MD, Assistant Professor of Medicine at the Columbia University College of
Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator
of the study, will describe the ability of AFM13 to engage innate immunity through specific
activation of NK cells in tumors expressing CD30 and the impact of these effects on clinical
outcome. Updated data from this study with AFM13 monotherapy in relapsed or
refractory CD30-positive lymphoma with cutaneous lesions showed a 50% ORR in three
dose cohorts (n=8), including one CR (13%) and three partial responses, or PRs (38%). The
presentation will also discuss the immunologic changes in the tumor and peripheral blood
- Cord Blood Derived Natural Killer Cells Loaded with a Tetravalent Bispecific Antibody
Construct (AFM13) As Off-the-Shelf Cell Therapy for CD30+ Malignancies to be
Highlighted in Oral Presentation at 2018 ASH. The combination of expanded allogeneic
cord-blood derived Natural Killer cells preloaded with AFM13 to redirect the specificity of
NK cells against CD30-positive malignancies in preclinical models will be discussed in an
oral presentation. The data provide a strong rationale for testing this combined, redirected
off-the-shelf cellular product to further increase response rates and durability of responses
in patients with relapsed/refractory CD30+ lymphoma. This new approach was led by Katy
Rezvani, MD, PhD and her team at the Department of Stem Cell Transplantation and
Cellular Therapy, The University of Texas MD Anderson Cancer Center (MDACC) under
Affimed’s multi-year sponsored research collaboration with MDACC.
- Following discussions with the U.S. Food and Drug Administration on future development
plans for AFM13, Affimed is working with clinical experts to finalize the registrational study
designs for AFM13 and will provide an update in early December.
- Affimed selected the development candidate in its AFM24 program and successfully
completed a toxicology assessment in cynomolgus monkeys at a range of dose levels up to
75mg/kg over 4 weeks with no observed toxicities even at high dose levels. AFM24 is
designed to treat patients with a variety of EGFR expressing solid tumors with the potential
for better efficacy and safety as compared to current therapeutic anti-EGFR monoclonal
antibodies that are associated with significant toxicities. Affimed continues to anticipate
completing IND-enabling studies by mid-2019.
Other Innate Immunity Engager Opportunities and AFM26 (BCMA/CD16A)
- Additional abstracts to be presented at the 2018 ASH Annual Meeting include an update
on Affimed’s research on the role of CD16A specific immune cell engagers and activation
of CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data
regarding its partnered program for AFM26 (BCMA/CD16A) in multiple myeloma.
T cell engager programs
- Preliminary Results from Phase 1 Study of AFM11 in Relapsed/Refractory Acute
Lymphoblastic Leukemia (ALL) to be Presented at 2018 ASH. Data will be presented on
the clinical activity and safety of AFM11, a CD19/CD3-targeting tetravalent bispecific T cell
engager in Affimed’s Phase 1 dose escalation trial in relapsed/refractory ALL. An ASH
abstract released on November 1, 2018 showed two complete responses with complete
hematological recovery, including one pt achieving minimal residual disease (MRD)
- In October, Affimed announced that AFM11 is on clinical hold after the occurrence of
Serious Adverse Events (SAEs) in three patients. Affimed is assessing all of the data from
the AFM11 program and will be working with global health authorities to determine next
steps for the program. Affimed intends to provide an update on AFM11 upon completion
of the evaluation.
(Figures for the third quarter and nine months ended September 30, 2018 and 2017 represent
Cash and cash equivalents totaled €37.1 million as of September 30, 2018 compared to €39.8
million as of December 31, 2017. Affimed’s operational expenses were largely offset by net
proceeds of €19.7 million from the public offering in February 2018. Pro forma cash and cash
equivalents as of September 30, 2018, including the $96.0 million (€82.9 million) payment
received from Genentech at the end of October 2018, would have been €120.0 million ($138.9
Net cash used in operating activities was €24.9 million for the nine months ended September 30,
2018 compared to €20.7 million for the nine months ended September 30, 2017. The increase was
primarily related to higher cash expenditure for research and development (R&D) in connection
with Affimed’s clinical development programs and early stage development activities.
Revenue for the third quarter of 2018 was €0.3 million compared to €0.5 million for the third
quarter of 2017. Revenue in both periods was solely derived from AbCheck services.
R&D expenses for the third quarter of 2018 were €9.8 million compared to €6.0 million for the
third quarter of 2017. The increase was primarily related to higher expenses for early stage
development and discovery activities.
G&A expenses for the third quarter of 2018 were higher at €2.4 million compared to €1.9 million
for the third quarter of 2017.
Net loss for the third quarter of 2018 was at €12.0 million, or €0.19 per common share, compared
to a net loss of €8.1 million, or €0.18 per common share, for the third quarter of 2017. The increase
in operating expenses was primarily related to higher R&D expenses.
Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in
accordance with International Financial Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB). None of the financial statements were prepared in
accordance with Generally Accepted Accounting Principles (GAAP) 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, Wednesday, November 7, 2018 at 8:30
a.m. Eastern time to discuss the company’s financial results and recent corporate developments.
To access the call, please dial (323) 794-2588 for U.S. callers, or +44 (0)330 336 9125 for
international callers, and reference conference ID 6650897 approximately 15 minutes prior to the
call. An audio webcast of the conference call can be accessed in the “Events” section on the
“Investors & Media” page of Affimed’s website at http://www.affimed.com/events.php. A replay
of the webcast will be available on Affimed’s website shortly after the conclusion of the call and
will be archived for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by
harnessing the power of innate and adaptive immunity (NK cells, macrophages and T cells). We
are developing single and combination therapies to treat cancers and other life-threatening
diseases. For more information, please visit www.affimed.com.
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,
expectations regarding 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 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 Contact:
Head of Investor Relations
Affimed Media Contact:
Head of Communications, EU IR