- AFM13 monotherapy: Reported positive
data from the preplanned interim analysis for the
registration-directed trial in PTCL
- AFM13 combination with NK cells:
Announced 100% objective response rate in four response evaluable
patients, including 2 complete responses
- AFM24 monotherapy: AFM24 (phase 1/2a
study) completed cohort 4 and is enrolling and treating patients in
cohort 5; expansion cohorts expected to start in the second half of
2021
- AFM24 combination with NK cells: IND
application cleared by the FDA for the combination of AFM24 with
NKGen Biotech’s SNK-01 NK autologous cell therapy
- AFM24 combination with anti PD-L1
antibody: Established a collaboration with Roche to clinically
explore the combination of AFM24 with atezolizumab
(Tecentriq®)
- Made continued progress in advancing
and forming partnerships with Genentech and Roivant, which
triggered payments to Affimed
- Pro forma cash and cash equivalents
as of December 31, 2020 were approximately €244.5 million
(inclusive of Q1 equity offering and loan proceeds) with
anticipated cash runway into the second half of 2023
- Conference call and webcast
scheduled for April 15, 2021 at 8:30 a.m. EDT
Heidelberg, Germany, April 15, 2021 – 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 year ended
December 31, 2020 and provided an update on clinical and corporate
progress.
“2020 was an important year for Affimed. We continued to build
on the strong foundation of our scientific discoveries and made
significant progress across all our programs. We broadened our
clinical pipeline, added new collaborations, built a strong balance
sheet, appointed key senior management executives and ensured that
our programs stayed on track through the global pandemic,” said Dr.
Adi Hoess, CEO of Affimed. “We entered 2021 with strong momentum,
and the recently announced positive outcome of our interim futility
analysis for our registration directed study of AFM13 as
monotherapy in PTCL patients, and initial data from the trial
investigating AFM13 pre-complexed natural killer cells in Hodgkin
lymphoma patients provide further validation for our three-pronged
development strategy. As we look ahead into 2021, we anticipate
numerous additional updates as we advance our programs.”
Clinical Stage Program Updates
Three-pronged Development Strategy
Based on preclinical and clinical data, Affimed is pursuing
development of its innate cell engagers (ICE®) as monotherapy, and
in combination with adoptive NK cell transfer and PD-1/PD-L1
checkpoint inhibitors.
AFM13 (CD30/CD16A)
- In March 2021, Affimed reported
positive results from the preplanned interim futility analysis for
AFM13-202, its phase 2 registration-directed study of AFM13
(CD16A/CD30) as monotherapy in patients with relapsed or refractory
CD30-positive peripheral T-cell lymphoma (PTCL). The
futility analysis demonstrated that the response rate in Cohort A
achieved the predefined threshold for continuation of the study.
The response rate in Cohort B was sufficiently comparable to allow
merging of both cohorts into a single cohort for all patients with
CD30 >1%, per the study protocol. Evidence of anti-tumor
response was observed in both cohorts with complete and partial
responses. The trial will continue by combining the high- and
low-CD30 expressing cohorts into one.
- In April 2021, Affimed reported
positive initial clinical data from the investigator sponsored
trial (IST) at The University of Texas MD Anderson Cancer Center
evaluating increasing doses of cord-blood derived NK cells
pre-complexed with AFM13 (CD16A/CD30) followed by three weekly
infusions of AFM13 monotherapy in patients with recurrent or
refractory CD30 positive lymphomas. As of March 31, 2021, all four
response evaluable patients, including three patients in cohort 1
(1x106 AFM13-cbNK/kg) and one patient in cohort 2 (1x107
AFM13-cbNK/kg), have achieved an objective response, including two
complete responses, according to investigator assessments by
Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All
four patients had relapsed / refractory Hodgkin lymphoma and were
heavily pretreated, with between four and 14 previous lines of
therapy which in all cases included brentuximab vedotin (Adcetris®)
and anti-PD1 antibodies.
AFM24 (EGFR/CD16A)
- AFM24-101, the phase 1/2a clinical trial of AFM24, the
EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid
tumors, completed dose cohort 4 (160 mg) and patients are currently
being enrolled and treated in dose cohort 5 (320 mg). Affimed
expects to provide an update on the dose escalation and initiate
the dose expansion cohorts during 2021.
- An investigational new drug (IND) application was cleared by
the U.S. Food and Drug Administration to investigate the
combination of AFM24 with NKGen Biotech’s (formerly known as NKMax
America) autologous NK cell therapy, SNK01, in a first-in-human
proof of concept (POC) trial in patients with EGFR-expressing
tumors. Affimed expects to initiate the study in the second half of
2021.
- Affimed entered into a clinical collaboration with Roche for a
phase 1/2a study evaluating AFM24 in combination with the PD-L1
checkpoint inhibitor atezolizumab (Tecentriq®) in EGFR-expressing
solid tumors. The phase 1 portion of the study will establish a
dosing regimen and assess safety for the combination; in the
subsequent phase 2a portion of the study, the clinical activity of
the combination will be evaluated in specific tumor types. Affimed
expects to initiate the study in the second half of 2021.
- Preclinical data was presented at AACR 2021 showing the
potential of AFM24 as monotherapy and in combination with NK cells.
As monotherapy, AFM24 induces tumor cell killing independent of
KRAS mutations; and, in combination with adoptive NK cells, it
leads to AFM24 dose-dependent tumor regression.
Preclinical and Partnered Programs
- AFM28 progressed further in IND-enabling studies and Affimed
expects an IND application will be filed in the first half of
2022.
- In November 2020, Affimed entered into a licensing and
strategic collaboration agreement with Roivant Sciences and granted
Roivant a license to AFM32 with options for additional ICE®
molecules against targets not included in Affimed’s current
pipeline. AFM32 will be investigated in solid tumors.
- In August 2020, Affimed announced that Genentech’s RO7297089, a
CD16A/BCMA targeting ICE®, is actively recruiting patients into a
first-in-human phase 1 trial resulting in the achievement of a
milestone payment under the terms of the collaboration.
- Affimed entered a collaboration with Artiva Biotherapeutics to
assess feasibility and activity of pre-manufactured, co-vialed,
cryopreserved, off-the-shelf NK cell combination therapeutics. The
R&D collaboration is assessing the feasibility and preclinical
activity of combinations of Artiva’s allogeneic NK cell product
AB-101 and Affimed’s ICE® molecules, building on earlier
preclinical studies demonstrating synergistic cytotoxic
activity.
Other Corporate Updates
- In January 2021, Affimed completed a $115 million underwritten
public offering to accelerate and expand the development and
manufacturing of its clinical and preclinical ICE® molecules.
- In January 2021, Affimed entered into a financing agreement
with Silicon Valley Bank for up to €25 million in term loans, with
€10 million available at closing.
Full Year 2020 Financial Highlights
As of December 31, 2020, cash, cash equivalents and current
financial assets totaled €146.9 million compared to €104.1 million
on December 31, 2019. The pro forma cash position as of December
31, 2020, including net proceeds from the January 2021 underwritten
public offering and the first tranche of the Silicon Valley Bank
loan, would be approximately €244.5 million.
Based on its current operating plan and assumptions, Affimed
anticipates that its cash and cash equivalents will support
operations into the second half of 2023.
Net cash used in operating activities for the year ended
December 31, 2020 amounted to €19.4 million compared to €29.1
million for the year ended December 31, 2019. The amount received
in 2020 includes an initial upfront payment and committed funding
of €33.3 million (US$ 40 million) from the Roivant
collaboration.
Total revenue for the year ended December 31, 2020 was €28.4
million compared with €21.4 million for the year ended December 31,
2019. Revenue for 2020 and 2019 predominantly relate to the
Genentech collaboration. Collaboration revenue for the year ended
December 31, 2020 amounted to €27.8 million, with €26.2 million
from the Genentech collaboration and €1.4 million from the Roivant
collaboration. Collaboration revenue of €19.7 million for the year
ended December 31, 2019 was from the Genentech collaboration.
Research and development expenses for 2020 increased 14.2% from
€43.8 million in the year ended December 31, 2019 to €50.0 million
in the year ended December 31, 2020, due to higher expenses for
AFM24 and our other projects and infrastructure investments.
General and administrative expenses increased 33.6% from €10.3
million in the year ended December 31, 2019 to €13.7 million in the
year ended December 31, 2020. In 2020, general and administrative
expenses were largely comprised of personnel expenses of €6.3
million and legal, consulting and audit costs of €5.6 million.
Finance costs for the year ended December 31, 2020 were €6.6
million, compared to finance income of €15 thousand for the year
ended December 31, 2019. Finance costs for the year ended December
31, 2020 were largely comprised of foreign exchange losses related
to assets denominated in U.S. dollars as a result of the weakening
of the U.S. dollar compared to the Euro during the year.
Net loss for the year ended December 31, 2020 was €41.4 million,
or €0.50 per common share compared with a net loss of €32.4
million, or €0.50 per common share, for the year ended December 31,
2019.
The weighted number of common shares outstanding for the year
ended December 31, 2020 was 83.5 million.
Additional information regarding these results is included in
the notes to the consolidated financial statements as of December
31, 2020 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 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, April 15,
2021 at 8:30 a.m. EDT to discuss fourth quarter, year-end 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 4271307 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 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 by actualizing the untapped potential of the innate
immune system. The company’s proprietary ROCK® platform enables a
tumor-targeted approach to recognize and kill a range of
hematologic and solid tumors, enabling a broad pipeline of
wholly-owned and partnered single agent and combination therapy
programs. The ROCK® platform predictably generates customized
innate cell engager (ICE®) molecules, which use patients’ immune
cells to destroy tumor cells. This innovative approach enabled
Affimed to become the first company with a clinical-stage ICE®.
Headquartered in Heidelberg, Germany, with offices in New York, NY,
Affimed is led by an experienced team of biotechnology and
pharmaceutical leaders united by a bold vision to stop cancer from
ever derailing patients’ lives. For more about the company’s
people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statements
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 potential of AFM13, AFM24, and
our other product candidates, 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, 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, impacts of
the COVID-19 pandemic, the benefits to Affimed of orphan drug
designation and the risks, uncertainties and other factors
described under the heading “Risk Factors” in Affimed’s filings
with the SEC. 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.
Investor Relations Contact
Alexander FudukidisDirector, Head of Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Affimed N.V.
Consolidated statements of comprehensive
income / (loss) (in € thousand)
|
|
2020 |
|
2019 |
|
2018 |
Revenue |
|
28,360 |
|
21,391 |
|
23,735 |
Other income - net |
|
626 |
|
290 |
|
1,515 |
Research and development
expenses |
|
(49,989) |
|
(43,791) |
|
(35,148) |
General and administrative
expenses |
|
(13,715) |
|
(10,266) |
|
(9,638) |
Operating
loss |
|
(34,718) |
|
(32,376) |
|
(19,536) |
Finance
income / (costs)
- net |
|
(6,647) |
|
15 |
|
60 |
Loss
before tax |
|
(41,365) |
|
(32,361) |
|
(19,476) |
Income taxes |
|
(1) |
|
(4) |
|
(1) |
Loss
for the
period |
|
(41,366) |
|
(32,365) |
|
(19,477) |
Other
comprehensive income
/ (loss) |
|
|
|
|
|
|
Items
that will not
be reclassified
to profit or
lossEquity investments at fair value OCI - net
change in |
|
|
|
|
|
|
fair value |
|
(242) |
|
(632) |
|
(4,731) |
Other
comprehensive income
/ (loss) |
|
(242) |
|
(632) |
|
(4,731) |
Total
comprehensive Loss |
|
(41,608) |
|
(32,997) |
|
(24,208) |
Earnings /
(loss) per share
in € per
share (undiluted =
diluted) |
|
(0.50) |
|
(0.50) |
|
(0.32) |
Weighted
number of common
shares outstanding |
|
83,471,559 |
|
64,242,396 |
|
60,514,407 |
Affimed N.V.Consolidated
statements of financial position (in € thousand)
ASSETS |
|
December 31,
2020 |
|
December 31,
2019 |
Non-current
assets |
|
|
|
|
Intangible assets |
|
1,718 |
|
137 |
Leasehold improvements and
equipment |
|
2,226 |
|
2,291 |
Long term financial assets |
|
20,042 |
|
3,193 |
Right-of-use assets |
|
940 |
|
824 |
|
|
24,926 |
|
6,445 |
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
146,854 |
|
95,234 |
Financial assets |
|
0 |
|
8,902 |
Trade and other receivables |
|
2,439 |
|
1,482 |
Inventories |
|
246 |
|
296 |
Other assets |
|
1,260 |
|
0 |
|
|
150,799 |
|
105,914 |
TOTAL
ASSETS |
|
175,725 |
|
112,359 |
EQUITY
AND LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Issued capital |
|
983 |
|
762 |
Capital reserves |
|
345,164 |
|
270,451 |
Fair value reserves |
|
1,720 |
|
1,962 |
Accumulated deficit |
|
(275,874) |
|
(234,508) |
Total
equity |
|
71,993 |
|
38,667 |
Non-current
liabilities |
|
|
|
|
Borrowings |
|
231 |
|
278 |
Contract liabilities |
|
35,992 |
|
37,961 |
Lease liabilities |
|
482 |
|
272 |
Total
non-current liabilities |
|
36,705 |
|
38,511 |
Current
liabilities |
|
|
|
|
Trade and other payables |
|
11,394 |
|
10,674 |
Provisions |
|
0 |
|
517 |
Borrowings |
|
92 |
|
2,105 |
Lease liabilities |
|
492 |
|
532 |
Contract liabilities |
|
55,049 |
|
21,353 |
Total
current liabilities |
|
67,027 |
|
35,181 |
TOTAL
EQUITY AND
LIABILITIES |
|
175,725 |
|
112,359 |
Affimed N.V.Consolidated
statements of cash flows (in €
thousand)
Cash flow from operating
activities |
2020 |
|
2019 |
|
2018 |
Income / (loss) for the
period |
(41,366) |
|
(32,365) |
|
(19,477) |
Adjustments for the period: |
|
|
|
|
|
- Income taxes |
1 |
|
4 |
|
1 |
- Depreciation and
amortisation |
1,115 |
|
906 |
|
403 |
- Net gain / loss from disposal
of leasehold improvements and equipment |
34 |
|
(5) |
|
25 |
- Share based payments |
3,381 |
|
2,469 |
|
2,035 |
- Finance income / costs -
net |
6,647 |
|
(15) |
|
(60) |
|
(30,188) |
|
(29,006) |
|
(17,073) |
Change in trade and other
receivables |
(1,065) |
|
33 |
|
(322) |
Change in inventories |
50 |
|
(36) |
|
(19) |
Change in other assets |
(1,260) |
|
340 |
|
121 |
Change in trade, other payables,
provisions and contract liabilities |
12,848 |
|
(791) |
|
66,856 |
Cash used in operating
activities |
(19,615) |
|
(29,460) |
|
49,563 |
Interest received |
294 |
|
628 |
|
218 |
Paid interest |
(78) |
|
(224) |
|
(342) |
Paid income tax |
(1) |
|
0 |
|
(1) |
Net cash used in
operating activities |
(19,400) |
|
(29,056) |
|
49,438 |
Cash flow from investing
activities |
|
|
|
|
|
Purchase of intangible
assets |
(9) |
|
(150) |
|
(30) |
Purchase of leasehold
improvements and equipment |
(431) |
|
(1,324) |
|
(691) |
Cash received from the sale of
leasehold improvements and equipment |
0 |
|
0 |
|
1 |
Cash paid for investments in
financial assets |
(8,101) |
|
(45,131) |
|
(14,029) |
Cash received from maturity of
financial assets |
16,547 |
|
50,945 |
|
0 |
Cash paid for investments in long
term financial assets |
0 |
|
0 |
|
(861) |
Net cash used for
investing activities |
8,006 |
|
4,340 |
|
(15,610) |
Cash flow from financing
activities |
|
|
|
|
|
Proceeds from issue of common
shares |
74,195 |
|
31,373 |
|
25,113 |
Transaction costs related to
issue of common shares |
(2,294) |
|
(2,215) |
|
(1,701) |
Proceeds from borrowings |
0 |
|
562 |
|
0 |
Repayment of lease
liabilities |
(521) |
|
(405) |
|
0 |
Repayment of borrowings |
(2,128) |
|
(3,277) |
|
(2,917) |
Cash flow from financing
activities |
69,252 |
|
26,038 |
|
20,495 |
Exchange-rate related changes of cash and cash
equivalents |
(6,238) |
|
(917) |
|
669 |
Net changes to cash and
cash equivalents |
57,858 |
|
1,322 |
|
54,323 |
Cash and cash equivalents
at the beginning of the period |
95,234 |
|
94,829 |
|
39,837 |
Cash and cash equivalents
at the end of the period |
146,854 |
|
95,234 |
|
94,829 |
Affimed N.V.Consolidated
statements of changes in equity (in € thousand)
|
Issued capital |
|
Capital reserves |
|
Fair value reserves |
|
Accumulateddeficit |
|
Total equity |
Balance
as of January 1, 2018 |
468 |
|
213,778 |
|
7,325 |
|
(182,667) |
|
38,904 |
Issue of common
shares |
156 |
|
23,171 |
|
|
|
|
|
23,327 |
Exercise of share based payment
awards |
|
|
71 |
|
|
|
|
|
71 |
Equity-settled share based
payment awards |
|
|
2,035 |
|
|
|
|
|
2,035 |
Loss for the period |
|
|
|
|
|
|
(19,477) |
|
(19,477) |
Other comprehensive income |
|
|
|
|
(4,731) |
|
|
|
(4,731) |
Balance
as of December 31, 2018 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Balance
as of January 1, 2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Issue of common
shares |
138 |
|
28,901 |
|
|
|
|
|
29,039 |
Exercise of share based payment
awards |
|
|
26 |
|
|
|
|
|
26 |
Equity-settled share based
payment awards |
|
|
2,469 |
|
|
|
|
|
2,469 |
Loss for the period |
|
|
|
|
|
|
(32,365) |
|
(32,365) |
Other comprehensive income |
|
|
|
|
(632) |
|
|
|
(632) |
Balance
as of December 31, 2019 |
762 |
|
270,451 |
|
1,962 |
|
(234,508) |
|
38,667 |
Balance as of January 1,
2020 |
762 |
|
270,451 |
|
1,962 |
|
(234,508) |
|
38,667 |
Issue of common
shares |
205 |
|
68,341 |
|
|
|
|
|
68,546 |
Exercise of share based payment
awards |
16 |
|
2,991 |
|
|
|
|
|
3,007 |
Equity-settled share based
payment awards |
|
|
3,381 |
|
|
|
|
|
3,381 |
Loss for the period |
|
|
|
|
|
|
(41,366) |
|
(41,366) |
Other comprehensive income |
|
|
|
|
(242) |
|
|
|
(242) |
Balance
as of December 31, 2020 |
983 |
|
345,164 |
|
1,720 |
|
(275,874) |
|
71,993 |
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Sep 2023 to Sep 2024