Press Release: Affimed Reports Third Quarter 2020 Financial Results and Highlights Recent Operational Progress
-- Established license and strategic collaboration with Roivant Sciences -
$60 million in upfront consideration and up to $2 billion in future
milestones
-- Recognized milestone payment from Genentech for initiation of Phase 1 of
RO7297089
-- Ended quarter with EUR97.3 million of cash, cash equivalents and current
financial assets with anticipated cash runway into first half of 2023
-- AFM13 pTCL REDIRECT monotherapy study -- interim analysis expected during
first half of 2021
-- AFM24 (Phase 1/2a) completed cohort 2 and is enrolling and treating
patients in cohort 3
-- First patient dosed with preloaded AFM13 allogeneic cord blood-derived
natural killer cells at MD Anderson Cancer Center
-- Collaborations formed with NKMax America and Artiva Biotherapeutics to
accelerate innate cell engager (ICE(R)) / NK cell therapy combinations
-- Data from one preclinical and two clinical studies to be presented at
upcoming SITC and ASH scientific conferences
-- Conference call and webcast scheduled for November 10, 2020 at 8:30 am
EST
Heidelberg, Germany, November 10, 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 three and nine months ended September 30, 2020 and provided an
update on clinical and corporate progress.
"We have made significant progress with regards to executing our
strategy by advancing the development of our innate cell engagers as
monotherapy and in combinations. The partnership with Roivant Sciences
broadens our pipeline and advances AFM32 towards clinical development;
proceeds from the deal extend our cash runway into 2023," said Dr. Adi
Hoess, CEO of Affimed. "In addition, we have secured important new NK
cell collaborations that broaden the development of our lead therapeutic
candidates. As we move ahead, we look forward to reporting on progress
of the different programs and generating additional data."
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
-- AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy
in relapsed or refractory patients with CD30-positive peripheral T-cell
lymphoma (pTCL), has recruited the prespecified number of patients for
the preplanned interim analysis. Affimed now expects to complete the
interim data analysis during the first half of 2021.
-- AFM13-104, an investigator sponsored Phase 1 study at MD Anderson Cancer
Center evaluating the tolerability and efficacy of AFM13 preloaded cord
blood-derived NK (cbNK) cells followed by weekly AFM13 monotherapy in
patients with refractory CD30 expressing lymphomas, reported that the
first patient has completed the first four-week cycle without noteworthy
toxicity and has achieved a partial response according to investigator
assessment. The patient is intended to receive a second treatment cycle.
-- An oral presentation of the preclinical data from the collaborations with
MD Anderson Cancer Center and the University of Washington combining
allogeneic cbNK cells preloaded with AFM13 will be presented at the 35th
Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on
November 11th.
-- Two abstracts on studies with AFM13 have been accepted for poster
presentation at the 62nd American Society of Hematology Annual Meeting
and Exposition (ASH). The data presented will be from Columbia
University's AFM13 study in patients with relapsed or refractory
CD30-positive lymphoma with cutaneous presentation and data from the
German Hodgkin Study Group study in patients with relapsed or refractory
Hodgkin Lymphoma.
AFM24 (EGFR/CD16A)
-- AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted
ICE(R) for patients with EGFR-expressing solid tumors, completed dose
cohort 2 and patients are currently being enrolled and treated in cohort
3.
-- Affimed entered a clinical collaboration to investigate the combination
of AFM24 with NKMax America's autologous NK cell therapy, SNK01, in a
first-in-human proof of concept (POC) trial in patients with
EGFR-expressing tumors. The agreement includes an option to broaden the
collaboration to include NKMax America's allogeneic NK cell product. The
agreement follows a preclinical collaboration between the two companies
that showed synergy between Affimed's ICE(R) molecules and NKMax
America's autologous and cryopreserved allogeneic NK cell products.
Roivant Sciences Partnership
-- Affimed entered into a licensing and strategic collaboration agreement
with Roivant Sciences under which the Company will receive $60 million in
upfront consideration, including $40 million in cash and pre-funded R&D
and $20 million of Roivant equity, up to an additional $2 billion in
future milestones and tiered royalties.
-- Affimed will grant a license to AFM32 with options for additional ICE(R)
molecules directed against targets not included in Affimed's current
pipeline.
-- Affimed to be responsible for all preclinical work through IND-filing.
-- Roivant Sciences to form new subsidiary focused on the development and
commercialization of ICE(R)-based therapeutics.
-- Affimed retains certain co-promotional rights.
Genentech Partnership
-- The Genentech-partnered, novel BCMA-targeted innate cell engager for the
treatment of multiple myeloma is treating patients in a first-in-human
Phase I, open-label, multicenter, global dose-escalation study designed
to evaluate the safety, tolerability, and pharmacokinetics of RO7297089.
-- The initiation of the Phase 1 study triggered a milestone payment
recognized in the third quarter.
Preclinical Pipeline Update
-- AFM28 progressed further in IND-enabling studies and Affimed expects an
IND will be filed in the first half of 2022.
-- Affimed entered a R&D collaboration with Artiva Biotherapeutics to
develop off-the-shelf, cryopreserved, co-vialed allogeneic natural killer
(NK) cell therapeutics pre-loaded with its ICE(R) compounds.
Third Quarter 2020 Financial Highlights
(Figures for the third quarter ended September 30, 2020 and 2019 are
unaudited.)
As of September 30, 2020, cash, cash equivalents and current financial
assets totaled EUR97.3 million compared to EUR104.1 million on December
31, 2019. The pro forma cash position of the company as of September 30,
2020, including the $40 million of upfront cash proceeds from the
Roivant collaboration, would be EUR131.5 million. During the quarter,
the company received net proceeds of approximately EUR11.6 million under
its at-the-market ("ATM") program and a milestone payment from its
partnership with Genentech in an undisclosed amount.
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 2023.
Net cash used in operating activities for the quarter ended September
30, 2020 was EUR3.6 million compared to EUR11.7 million in the third
quarter of 2019.
Total revenue for the third quarter of 2020 was EUR10.5 million compared
with EUR2.1 million in the third quarter of 2019. Revenue for the third
quarter of 2020 and 2019 predominantly relate to the Genentech
collaboration (2020: EUR10.5 million, 2019: EUR1.9 million). Revenue
from the Genentech collaboration in the third quarter 2020 was comprised
of revenue recognized for collaborative research services performed
during the quarter and the recognition of revenue related to a milestone
payment.
R&D expenses for the third quarter of 2020 were EUR10.1 million compared
to EUR11.7 million in the third 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 third quarter of 2020 were EUR3.5 million compared
to EUR2.8 million in the third quarter of 2019.
Net loss for the third quarter of 2020 was EUR6.0 million or EUR0.07 per
common share. For the third quarter of 2019, the company's net loss was
EUR10.9 million or EUR0.17 per common share.
The weighted number of common shares outstanding for the quarter ended
September 30, 2020 were 86.0 million.
Affimed encourages shareholders to also review its 6-K filing for the
quarter ended September 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, November
10, 2020 at 8:30 a.m. EST to discuss third 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
9847055 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/. A replay of the webcast
(MORE TO FOLLOW) Dow Jones Newswires
November 10, 2020 06:30 ET (11:30 GMT)
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