- 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 €97.3 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®) / 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® 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® 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® 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®-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® 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 €97.3 million compared to €104.1 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 €131.5 million.
During the quarter, the company received net proceeds of
approximately €11.6 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 €3.6 million compared to €11.7 million in
the third quarter of 2019.
Total revenue for the third quarter of 2020 was €10.5 million
compared with €2.1 million in the third quarter of 2019. Revenue
for the third quarter of 2020 and 2019 predominantly relate to the
Genentech collaboration (2020: €10.5 million, 2019: €1.9 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 €10.1
million compared to €11.7 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 €3.5 million
compared to €2.8 million in the third quarter of 2019.
Net loss for the third quarter of 2020 was €6.0 million or €0.07
per common share. For the third quarter of 2019, the company’s net
loss was €10.9 million or €0.17 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 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® platform allows
innate cell engagers to be designed for specific patient
populations. The company is developing single and combination
therapies to treat hematologic and solid tumors. The company is
currently enrolling patients into a registration-directed study of
AFM13 for CD30-positive relapsed/refractory peripheral T cell
lymphoma and into a Phase 1/2a dose escalation/expansion study of
AFM24 for the treatment of advanced EGFR-expressing solid tumors.
For more information, 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 FudukidisHead of Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: (917) 436-8102
Affimed
N.V.Unaudited consolidated statements of
comprehensive income / (loss) (in € thousand)
|
|
For the three monthsended September
30 |
For the nine monthsended September
30 |
|
|
2020 |
2019 |
2020 |
2019 |
|
|
|
|
|
|
Revenue |
|
10,545 |
2,103 |
18,614 |
17,464 |
|
|
|
|
|
|
Other income – net |
|
102 |
49 |
130 |
332 |
Research and development
expenses |
|
(10,101) |
(11,721) |
(33,247) |
(31,253) |
General and administrative
expenses |
|
(3,455) |
(2,790) |
(9,586) |
(7,566) |
|
|
|
|
|
|
Operating income /
(loss) |
|
(2,909) |
(12,359) |
(24,089) |
(21,023) |
|
|
|
|
|
|
Finance income / (costs)
– net |
|
(3,057) |
1,475 |
(2,404) |
1,655 |
|
|
|
|
|
|
Income / (loss) before
tax |
|
(5,966) |
(10,884) |
(26,493) |
(19,368) |
|
|
|
|
|
|
Income taxes |
|
0 |
0 |
0 |
(4) |
|
|
|
|
|
|
Income / (loss) for the
period |
|
(5,966) |
(10,884) |
(26,493) |
(19,372) |
|
|
|
|
|
|
Other comprehensive
income / (loss) Items that will not be
reclassified to profit or lossEquity investments at fair
valueOCI – net change in fair value |
|
(139) |
(555) |
(129) |
(531) |
|
|
|
|
|
|
Other comprehensive
income / (loss) |
|
(139) |
(555) |
(129) |
(531) |
|
|
|
|
|
|
Total comprehensive
income / (loss) |
|
(6,105) |
(11,439) |
(26,622) |
(19,903) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings / (loss) per
share in € per share |
|
(0.07) |
(0.17) |
(0.33) |
(0.31) |
(undiluted =
diluted) |
|
|
|
|
|
Weighted number of common
shares outstanding |
|
86,030,878 |
62,443,550 |
80,490,155 |
62,437,673 |
Affimed
N.V.Consolidated statements of
financial position (in € thousand)
|
September 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
93 |
|
137 |
Leasehold improvements and
equipment |
2,305 |
|
2,291 |
Long term financial
assets |
3,064 |
|
3,193 |
Right-of-use assets |
1,084 |
|
824 |
|
6,546 |
|
6,445 |
Current
assets |
|
|
|
Cash and cash equivalents |
89,656 |
|
95,234 |
Financial assets |
7,687 |
|
8,902 |
Trade and other
receivables |
2,552 |
|
1,482 |
Inventories |
410 |
|
296 |
Other assets |
1,087 |
|
0 |
|
101,392 |
|
105,914 |
TOTAL
ASSETS |
107,938 |
|
112,359 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
883 |
|
762 |
Capital reserves |
305,301 |
|
270,451 |
Fair value reserves |
1,833 |
|
1,962 |
Accumulated deficit |
(261,001) |
|
(234,508) |
Total
equity |
47,016 |
|
38,667 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
207 |
|
278 |
Contract liabilities |
15,203 |
|
37,961 |
Lease liabilities |
332 |
|
272 |
Total non-current
liabilities |
15,742 |
|
38,511 |
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
8,123 |
|
10,674 |
Provisions |
479 |
|
517 |
Borrowings |
1,070 |
|
2,105 |
Lease liabilities |
779 |
|
532 |
Contract liabilities |
34,729 |
|
21,353 |
Total current
liabilities |
45,180 |
|
35,181 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
107,938 |
|
112,359 |
Affimed
N.V.Unaudited consolidated statements of
cash flows (in € thousand)
(in €
thousand) |
For the nine months ended September
30 |
|
2020 |
2019 |
Cash flow from
operating activities |
|
|
Income / (loss) for the
period |
(26,493) |
|
(19,372) |
Adjustments for the
period: |
|
|
|
- Income taxes |
0 |
|
4 |
- Depreciation and
amortization |
821 |
|
648 |
- Net gain from disposal of
leasehold improvements and equipment |
0 |
|
(9) |
- Share based payments |
2,348 |
|
1,981 |
- Finance income / (costs) –
net |
2,404 |
|
(1,655) |
|
(20,920) |
|
(18,403) |
Change in trade and other
receivables |
(1,174) |
|
458 |
Change in inventories |
(114) |
|
(70) |
Change in other assets |
(1,087) |
|
(1,104) |
Change in trade, other
payables, provisions and contract liabilities |
(12,053) |
|
(11,727) |
Cash used in operating
activities |
(35,348) |
|
(30,846) |
Interest received |
299 |
|
413 |
Paid interest |
(81) |
|
(180) |
Net cash used in
operating activities |
(35,130) |
|
(30,613) |
|
|
|
|
Cash flow from
investing activities |
|
|
|
Purchase of intangible
assets |
(8) |
|
(143) |
Purchase of leasehold
improvements and equipment |
(352) |
|
(926) |
Cash paid for investments in
financial assets |
(8,101) |
|
(39,733) |
Cash received from maturity of
financial assets |
9,088 |
|
38,270 |
Net cash used for
investing activities |
627 |
|
(2,532) |
|
|
|
|
Cash flow from
financing activities |
|
|
|
Proceeds from issue of common
shares |
33,846 |
|
26 |
Transaction costs related to
issue of common shares |
(1,134) |
|
0 |
Proceeds from borrowings |
0 |
|
562 |
Repayment of lease
liabilities |
(386) |
|
(299) |
Repayment of borrowings |
(1,151) |
|
(2,339) |
Cash flow from
financing activities |
31,175 |
|
(2,050) |
|
|
|
|
Exchange-rate related
changes of cash and cash equivalents |
(2,250) |
|
361 |
Net changes to cash
and cash equivalents |
(3,328) |
|
(35,195) |
Cash and cash
equivalents at the beginning of the period |
95,234 |
|
94,829 |
Cash and cash
equivalents at the end of the period |
89,656 |
|
59,995 |
Affimed
N.V.Unaudited consolidated statements of
changes in equity (in € thousand)
|
Issued capital |
|
Capital reserves |
|
Fair Value reserves |
|
Accumulated deficit |
|
Total equity |
Balance as of January
1, 2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Exercise of share based
payment awards |
|
|
26 |
|
|
|
|
|
26 |
Equity-settled share based
payment awards |
|
|
1,981 |
|
|
|
|
|
1,981 |
Loss for the period |
|
|
|
|
|
|
(19,372) |
|
(19,372) |
Other comprehensive
income |
|
|
|
|
(531) |
|
|
|
(531) |
Balance as of
September 30, 2019 |
624 |
|
241,062 |
|
2,063 |
|
(221,516) |
|
22,233 |
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2020Balance as of January 1, 2020 |
762 |
|
270,451 |
|
1,962 |
|
(234,508) |
|
38,667 |
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
121 |
|
32,502 |
|
|
|
|
|
32,623 |
Equity-settled share based
payment awards |
|
|
2,348 |
|
|
|
|
|
2,348 |
Loss for the period |
|
|
|
|
|
|
(26,493) |
|
(26,493) |
Other comprehensive
income |
|
|
|
|
(129) |
|
|
|
(129) |
Balance as of
September 30, 2020 |
883 |
|
305,301 |
|
1,833 |
|
(261,001) |
|
47,016 |
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