-- 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 +1 (646) 741-3167 for U.S. callers, or
+44 (0) 2071 928338 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
(MORE TO FOLLOW) Dow Jones Newswires
August 11, 2020 06:30 ET (10:30 GMT)
