-- AFM24: First patient dosed in first-in-human clinical study for advanced
EGFR-expressing solid tumors, including colon, lung and other cancers
-- AFM13: Initiated registration-directed study in relapsed/refractory
peripheral T cell lymphoma; received FDA orphan drug designation for the
treatment of T cell lymphoma
-- CMO and CSO appointments strengthen executive management team and
position company to continue its leadership in innate immunity
-- Genentech collaboration: Affimed received milestone payment triggered by
Genentech's selection of final target; ongoing collaboration on track
with multiple programs progressing
-- Raised EUR29.5 million in net proceeds from a public equity offering in
November 2019
Heidelberg, Germany, April 28, 2020 - Affimed N.V. (Nasdaq: AFMD), a
clinical stage biopharmaceutical company committed to giving patients
back their innate ability to fight cancer, today reported financial
results for the year ended December 31, 2019 and provided an update on
clinical and corporate progress.
"Our clinical trials currently remain active, and we are working closely
with our participating physicians and clinical sites to minimize the
impact on further progress as they focus on addressing the evolving
COVID-19 global health crisis," said Dr. Adi Hoess, Affimed's CEO.
"During these unprecedented and challenging times, our top priority
continues to be supporting our employees, patients and our healthcare
partners, while ensuring the continuity of our operations."
Development Program Updates
Affimed remains committed to continuing its development programs but
acknowledges the impact from the evolving COVID-19 pandemic on clinical
studies, including potential delays in patient enrollment. The company
plans to update expected timing of milestones for its clinical studies
after there is more clarity on the duration and magnitude of the impact
from the COVID-19 pandemic.
AFM13 (CD30/CD16A)
-- Patient enrollment is ongoing in the Phase 2 registration-directed study
of AFM13 as a monotherapy in relapsed or refractory patients with
CD30-positive peripheral T cell lymphoma (pTCL). Affimed has successfully
activated 42 clinical study sites across nine countries.
-- To ensure patient safety and to avoid imposing additional burdens on
healthcare systems already strained by the COVID-19 pandemic, the company
has taken the decision to temporarily pause enrollment in the exploratory
cohort of patients with CD30-positive relapsed or refractory transformed
mycosis fungoides.
-- In March 2020, enrollment of all 15 patients was completed in an
investigator-sponsored Phase 1b/2a study of AFM13 in patients with
relapsed or refractory CD30-positive lymphoma with cutaneous
manifestation led by Columbia University. Previously reported data from
the study confirmed single-agent activity of AFM13, with an objective
response rate (ORR) of 50% (5 of 10 patients).
-- Affimed is in close collaboration with the University of Texas MD
Anderson Cancer Center (MDACC) to initiate an investigator-sponsored
Phase 1 study to investigate the combination of AFM13 with allogeneic NK
cells. MDACC intends to administer a stable complex of AFM13 pre-mixed
with cord blood-derived allogeneic NK cells in different doses (numbers
of pre-loaded NK cells) to patients with relapsed/refractory
CD30-positive lymphoid malignancies.
AFM24 (EGFR/CD16A)
-- The first patient was successfully dosed in a first-in-human Phase 1/2a
clinical trial of AFM24. The study is an open-label, non-randomized,
multi-center, multiple ascending dose escalation/expansion study to
evaluate AFM24 as monotherapy in patients with advanced solid
malignancies known to be EGFR-positive and whose disease has progressed
after treatment with previous anticancer therapies.
Preclinical Pipeline Update
-- Affimed continues to progress AFM28 and AFM32 as preclinical research
currently remains unimpacted by the COVID-19 pandemic.
Genentech Collaboration Update
-- In November 2019, Genentech exercised its final option for an exclusive
target under the ongoing, multi-program strategic oncology collaboration
agreement to develop and commercialize novel NK cell engager-based
immunotherapeutics generated from Affimed's ROCK(R) platform to treat
multiple cancers. Affimed received a payment from Genentech in an
undisclosed amount based on this achievement. Affimed and Genentech
continue to progress multiple programs under the ongoing strategic,
multi-target collaboration.
Management Appointments
-- Dr. Andreas Harstrick joined Affimed as Chief Medical Officer (CMO) in
March 2020 and Dr. Arndt Schottelius joined the company as Chief
Scientific Officer (CSO) in April 2020. Dr. Harstrick brings a track
record of running successful clinical trials that have led to regulatory
approvals, deep oncology expertise, and a proven ability to lead large
clinical organizations. Dr. Schottelius brings extensive innate immunity
expertise, R&D leadership and a successful record of advancing and
translating discovery research into preclinical and clinical development.
COVID-19 Impact Mitigation
COVID-19 has significantly impacted the global healthcare system,
including the conduct of clinical trials as medical institutions
prioritize the treatment of those afflicted with COVID-19. Affimed has
taken several important actions to balance the commitment to treat
cancer patients and to mitigate potential health and safety risks posed
by the COVID-19 pandemic, while maintaining continuity of its operations
and preserving financial flexibility for the future.
Full Year 2019 Financial Highlights
Cash, cash equivalents and current financial assets totaled EUR104.1
million as of December 31, 2019 compared to EUR108.8 million as of
December 31, 2018. During the fourth quarter of 2019, the company raised
EUR29.5 million in net proceeds, after deducting underwriting discounts
and commissions and estimated offering expenses, from a completed public
offering. Based on its current operating plan and assumptions, Affimed
anticipates that its cash, cash equivalents and current financial assets
as of December 31, 2019 will support operations at least into the first
half of 2022.
Net cash used in operating activities was EUR29.1 million for the twelve
months ended December 31, 2019, compared to net cash from operating
activities of EUR49.4 million for the twelve months ended December 31,
2018. The net cash from operating activities in 2018 includes an initial
upfront payment and committed funding of EUR83.2 million ($96.0 million)
from the strategic collaboration Affimed entered into with Genentech
Inc. in August 2018.
Total revenue was EUR21.4 million for the year ended December 31, 2019
compared to EUR23.7 million for the year ended December 31, 2018.
Revenue in both years is attributable primarily to the recognition of
revenue from the Genentech collaboration in the respective years.
Research and development (R&D) expenses were EUR43.8 million for the
year ended December 31, 2019, compared to EUR35.1 million for the year
ended December 31, 2018. The increase was primarily related to higher
expenses for startup activities for the AFM13 registration-directed
study in pTCL, manufacturing activities for AFM13 clinical study
material, and early stage development and discovery activities.
General and administrative (G&A) expenses were EUR10.3 million for the
year ended December 31, 2019, compared to EUR9.6 million for the year
ended December 31, 2018. In 2019, G&A expenses were primarily related to
personnel expenses and legal, consulting and audit costs.
Net loss was EUR32.4 million, or EUR0.50 per common share, for the year
ended December 31, 2019, compared to a net loss of EUR19.5 million, or
EUR0.32 per common share, for the year ended December 31, 2018.
Additional information regarding these results is included in the notes
to the consolidated financial statements as of December 31, 2019 and
"Item 5. Operating and Financial Review and Prospects," which will be
included in Affimed's Annual Report on Form 20-F as filed with the U.S.
Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports the 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, April
28, 2020 at 8:30 a.m. Eastern time to discuss the company's 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(R) platform allows innate cell engagers
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