- Established strategic collaboration agreement with Genentech
for NK cell engager-based immunotherapeutics: Received $96 million
in upfront and committed funding, may be eligible to receive up to
additional $5 billion over time, including payments upon
achievement of specified development, regulatory and commercial
milestones, plus royalties on sales -
- Six presentations highlighting Affimed's innate immunity and T
cell-based therapeutic programs will be presented at the 60th
American Society of Hematology (ASH) Annual Meeting -
- Updated data showed combination of AFM13 and Keytruda®
(pembrolizumab) achieved a 39% complete response rate and 87%
objective response rate in patients with relapsed/refractory
Hodgkin lymphoma -
- Updated data for AFM13 monotherapy showed a 50% objective
response rate in patients with relapsed/refractory CD30+ lymphoma
with cutaneous lesions -
- Company to host investor meeting on Friday, December 7, to
review clinical development strategy for AFM13 -
Heidelberg, Germany, November 7, 2018 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
focused on discovering and developing highly targeted cancer
immunotherapies that harness the power of innate and adaptive
immunity (NK cells, macrophages and T cells), today reported
financial and operational results for the quarter ended September
30, 2018.
"Our progress in the third quarter is
highlighted by the exciting strategic collaboration that we entered
into with Genentech based on our proprietary ROCK® platform," said
Dr. Adi Hoess, Affimed's CEO. "This partnership is a
transformational accomplishment for Affimed, and is based on both
our technology platform and expertise in innate immunity.
Separately, at the 2018 ASH Annual Meeting, we look forward to
sharing updated clinical data of AFM13 showing continued promising
signs of therapeutic efficacy both in combination with Keytruda® in
Hodgkin lymphoma and as monotherapy in CD30-positive lymphoma. We
are working toward finalizing our plans for a registrational
clinical study for AFM13 and will provide an update in early
December."
Investor Meeting on Friday, December 7, 2018
- Affimed will host a meeting with the investment community to
review the clinical development strategy for AFM13 on Friday,
December 7, 2018 in New York City. Topics will include future
planned clinical activities for AFM13 as monotherapy treatment and
in rational combinations. Further details will be announced closer
to the date of the meeting.
Collaboration Agreement with Genentech
- During the quarter, Affimed entered into a strategic
collaboration agreement with Genentech, a member of the Roche
Group, to develop and commercialize novel NK cell engager-based
immunotherapeutics based on Affimed's proprietary Redirected
Optimized Cell Killing (ROCK®) platform to treat multiple cancers.
On October 31, 2018, Affimed received $96 million in upfront and
committed funding, and may be eligible to receive up to an
additional $5 billion including payments on achievement of certain
development, regulatory and commercial milestones, plus royalties
on sales.
Third Quarter and Recent Pipeline Progress
CD16A innate immune cell engager programs
AFM13 (CD30/CD16A)
- Data from Phase 1b Combination Study of AFM13 with Merck's
Keytruda® (pembrolizumab) to be Presented at 2018 ASH. Affimed
will present data on all 30 patients (pts) administered the
combination of AFM13 with pembrolizumab at the 60th American
Society of Hematology (ASH) Annual Meeting. Key clinical outcomes,
including objective response rate (ORR) and complete response (CR)
rate will be released. An ASH abstract released on November 1, 2018
highlighted early data that showed an 87% ORR and a 39% CR rate in
23 evaluable pts from the highest dose cohort as of a June 29, 2018
data cut-off. Updated data for all pts (24 pts from the highest
dose cohort plus 6 pts treated at lower doses) will be presented at
ASH.
- Clinical and Biological Evaluation of AFM13 as Monotherapy
in Relapsed or Refractory CD30-Positive Lymphoma to be Presented at
2018 ASH. A poster presentation by Ahmed Sawas, MD, Assistant
Professor of Medicine at the Columbia University College of
Physicians and Surgeons and the New York-Presbyterian Hospital and
Principal Investigator of the study, will describe the ability of
AFM13 to engage innate immunity through specific activation of NK
cells in tumors expressing CD30 and the impact of these effects on
clinical outcome. Updated data from this study with AFM13
monotherapy in relapsed or refractory CD30-positive lymphoma with
cutaneous lesions showed a 50% ORR in three dose cohorts (n=8),
including one CR (13%) and three partial responses, or PRs (38%).
The presentation will also discuss the immunologic changes in the
tumor and peripheral blood over time.
- Cord Blood Derived Natural Killer Cells Loaded with a
Tetravalent Bispecific Antibody Construct (AFM13) As Off-the-Shelf
Cell Therapy for CD30+ Malignancies to be Highlighted in Oral
Presentation at 2018 ASH. The combination of expanded
allogeneic cord-blood derived Natural Killer cells preloaded with
AFM13 to redirect the specificity of NK cells against CD30-positive
malignancies in preclinical models will be discussed in an oral
presentation. The data provide a strong rationale for testing this
combined, redirected off-the-shelf cellular product to further
increase response rates and durability of responses in patients
with relapsed/refractory CD30+ lymphoma. This new approach was led
by Katy Rezvani, MD, PhD and her team at the Department of Stem
Cell Transplantation and Cellular Therapy, The University of Texas
MD Anderson Cancer Center (MDACC) under Affimed's multi-year
sponsored research collaboration with MDACC.
- Following discussions with the U.S. Food and Drug
Administration on future development plans for AFM13, Affimed is
working with clinical experts to finalize the registrational study
designs for AFM13 and will provide an update in early
December.
AFM24 (EGFR/CD16A)
- Affimed selected the development candidate in its AFM24 program
and successfully completed a toxicology assessment in cynomolgus
monkeys at a range of dose levels up to 75mg/kg over 4 weeks with
no observed toxicities even at high dose levels. AFM24 is designed
to treat patients with a variety of EGFR expressing solid tumors
with the potential for better efficacy and safety as compared to
current therapeutic anti-EGFR monoclonal antibodies that are
associated with significant toxicities. Affimed continues to
anticipate completing IND-enabling studies by mid-2019.
Other Innate Immunity Engager Opportunities and
AFM26 (BCMA/CD16A)
- Additional abstracts to be presented at the 2018 ASH Annual
Meeting include an update on Affimed's research on the role of
CD16A specific immune cell engagers and activation of CD16A
expressing macrophages to eliminate tumor cells, as well as
preclinical data regarding its partnered program for AFM26
(BCMA/CD16A) in multiple myeloma.
T cell engager programs
AFM11 (CD19/CD3)
- Preliminary Results from Phase 1 Study of AFM11 in
Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) to be
Presented at 2018 ASH. Data will be presented on the clinical
activity and safety of AFM11, a CD19/CD3-targeting tetravalent
bispecific T cell engager in Affimed's Phase 1 dose escalation
trial in relapsed/refractory ALL. An ASH abstract released on
November 1, 2018 showed two complete responses with complete
hematological recovery, including one pt achieving minimal residual
disease (MRD) negativity.
- In October, Affimed announced that AFM11 is on clinical hold
after the occurrence of Serious Adverse Events (SAEs) in three
patients. Affimed is assessing all of the data from the AFM11
program and will be working with global health authorities to
determine next steps for the program. Affimed intends to provide an
update on AFM11 upon completion of the evaluation.
Financial Highlights(Figures for the third quarter and
nine months ended September 30, 2018 and 2017 represent unaudited
figures)
Cash and cash equivalents totaled €37.1 million
as of September 30, 2018 compared to €39.8 million as of December
31, 2017. Affimed's operational expenses were largely offset by net
proceeds of €19.7 million from the public offering in February
2018. Pro forma cash and cash equivalents as of September 30, 2018,
including the $96.0 million (€82.9 million) payment received from
Genentech at the end of October 2018, would have been €120.0
million ($138.9 million).
Net cash used in operating activities was €24.9
million for the nine months ended September 30, 2018 compared to
€20.7 million for the nine months ended September 30, 2017. The
increase was primarily related to higher cash expenditure for
research and development (R&D) in connection with Affimed's
clinical development programs and early stage development
activities.
Revenue for the third quarter of 2018 was €0.3
million compared to €0.5 million for the third quarter of 2017.
Revenue in both periods was solely derived from AbCheck
services.
R&D expenses for the third quarter of 2018
were €9.8 million compared to €6.0 million for the third quarter of
2017. The increase was primarily related to higher expenses for
early stage development and discovery activities.
G&A expenses for the third quarter of 2018
were higher at €2.4 million compared to €1.9 million for the third
quarter of 2017.
Net loss for the third quarter of 2018 was at
€12.0 million, or €0.19 per common share, compared to a net loss of
€8.1 million, or €0.18 per common share, for the third quarter of
2017. The increase in operating expenses was primarily related to
higher R&D expenses.
Note on IFRS Reporting StandardsAffimed
prepares and reports the consolidated financial statements and
financial information in accordance with International Financial
Reporting Standards (IFRS) as issued by the International
Accounting Standards Board (IASB). None of the financial statements
were prepared in accordance with Generally Accepted Accounting
Principles (GAAP) in the United States. Affimed maintains its books
and records in Euro.
Conference Call and Webcast InformationAffimed will host
a conference call and webcast today, Wednesday, November 7, 2018 at
8:30 a.m. Eastern time to discuss the company's financial results
and recent corporate developments. To access the call, please dial
(323) 794-2588 for U.S. callers, or +44 (0)330 336 9125 for
international callers, and reference conference ID 6650897
approximately 15 minutes prior to the call. An audio webcast of the
conference call can be accessed in the "Events" section on the
"Investors & Media" page of Affimed's website at
http://www.affimed.com/events.php. A replay of the webcast will be
available on Affimed's website shortly after the conclusion of the
call and will be archived for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) engineers targeted
immunotherapies, seeking to cure patients by harnessing the power
of innate and adaptive immunity (NK cells, macrophages and T
cells). We are developing single and combination therapies to treat
cancers and other life-threatening diseases. For more information,
please visit www.affimed.com.
FORWARD-LOOKING STATEMENTSThis 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 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, expectations regarding
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 and the risks, uncertainties and
other factors described under the heading "Risk Factors" in
Affimed's filings with the Securities and Exchange Commission.
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.
Affimed Investor Contact:Gregory Gin,
Head of Investor RelationsE-Mail: IR@affimed.com
Affimed Media Contact:Anca Alexandru,
Head of Communications, EU IRE-Mail: media@affimed.com
AFFIMED N.V.CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS Affimed N.V.Unaudited
consolidated statements of comprehensive loss (in € thousand)
|
|
For the three months ended September 30 |
|
For the nine months ended September 30 |
|
|
2017 |
|
2018 |
|
2017 |
|
2018 |
Revenue |
|
467 |
|
306 |
|
1,374 |
|
988 |
|
|
|
|
|
|
|
|
|
Other income - net |
|
117 |
|
(259) |
|
201 |
|
(221) |
Research and
development expenses |
|
(6,008) |
|
(9,787) |
|
(16,881) |
|
(23,332) |
General and
administrative expenses |
|
(1,876) |
|
(2,389) |
|
(6,091) |
|
(6,591) |
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(7,300) |
|
(12,129) |
|
(21,397) |
|
(29,156) |
|
|
|
|
|
|
|
|
|
Finance income /
(costs) - net |
|
(800) |
|
109 |
|
(2,425) |
|
920 |
|
|
|
|
|
|
|
|
|
Loss before
tax |
|
(8,100) |
|
(12,020) |
|
(23,822) |
|
(28,236) |
|
|
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
0 |
|
20 |
|
(1) |
|
|
|
|
|
|
|
|
|
Loss for the
period |
|
(8,100) |
|
(12,020) |
|
(23,802) |
|
(28,237) |
|
|
|
|
|
|
|
|
|
Other comprehensive
income |
|
|
|
|
|
|
|
|
Items that will not
be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Equity investments at
fair value OCI - net change in fair value |
|
0 |
|
53 |
|
0 |
|
264 |
Other
comprehensive income |
|
0 |
|
53 |
|
0 |
|
264 |
|
|
|
|
|
|
|
|
|
Total comprehensive
loss |
|
(8,100) |
|
(11,967) |
|
(23,802) |
|
(27,973) |
|
|
|
|
|
|
|
|
|
Loss per share in € per share(undiluted =
diluted) |
|
(0.18) |
|
(0.19) |
|
(0.55) |
|
(0.47) |
Affimed N.V.Consolidated statements of
financial position (in € thousand)
|
|
December 31, 2017 |
|
September 30, 2018 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
|
|
|
|
Intangible assets |
65 |
|
63 |
Leasehold improvements
and equipment |
1,113 |
|
1,271 |
Long term financial
assets |
0 |
|
7,589 |
|
1,178 |
|
8,923 |
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Inventories |
241 |
|
320 |
Trade and other
receivables |
1,102 |
|
1,443 |
Other assets |
800 |
|
1,307 |
Cash and cash
equivalents |
39,837 |
|
37,076 |
|
41,980 |
|
40,146 |
|
|
|
|
TOTAL
ASSETS |
43,158 |
|
49,069 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
|
|
|
|
Issued capital |
468 |
|
624 |
Capital reserves |
213,778 |
|
238,539 |
Other reserves |
0 |
|
7,589 |
Accumulated
deficit |
(182,667) |
|
(210,904) |
Total
equity |
31,579 |
|
35,848 |
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
|
Borrowings |
4,086 |
|
2,244 |
Total non-current
liabilities |
4,086 |
|
2,244 |
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Trade and other
payables |
4,180 |
|
7,253 |
Borrowings |
3,083 |
|
3,083 |
Contract
liabilities |
230 |
|
641 |
Total current
liabilities |
7,493 |
|
10,977 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
43,158 |
|
49,069 |
Affimed N.V.Unaudited consolidated statements
of cash flows (in € thousand) |
|
For the nine months ended September 30 |
|
2017 |
|
2018 |
Cash flow from
operating activities |
|
|
|
Loss for the
period |
(23,802) |
|
(28,237) |
Adjustments for the
period: |
|
|
|
- Income taxes |
(20) |
|
1 |
- Depreciation and
amortization |
257 |
|
303 |
- Gain from disposal of
leasehold improvements and equipment |
(20) |
|
15 |
- Share based
payments |
1,494 |
|
1,523 |
- Finance income /
costs - net |
2,425 |
|
(920) |
|
(19,666) |
|
(27,315) |
Change in trade and
other receivables |
690 |
|
(344) |
Change in
inventories |
(85) |
|
(79) |
Change in other
assets |
(393) |
|
(549) |
Change in trade, other
payables and contract liabilities |
(1,044) |
|
3,473 |
Cash used in operating
activities |
(20,498) |
|
(24,814) |
Interest received |
48 |
|
159 |
Paid interest |
(229) |
|
(268) |
Paid income tax |
0 |
|
(1) |
Net cash used in
operating activities |
(20,679) |
|
(24,924) |
|
|
|
|
Cash flow from
investing activities |
|
|
|
Purchase of intangible
assets |
(26) |
|
(27) |
Purchase of leasehold
improvements and equipment |
(545) |
|
(448) |
Cash received from the
sale of leasehold improvements and equipment |
35 |
|
1 |
Cash paid for
investments in financial assets |
(13,114) |
|
0 |
Cash received from
maturity of financial assets |
13,425 |
|
0 |
Net cash used for
investing activities |
(225) |
|
(474) |
|
|
|
|
Cash flow from
financing activities |
|
|
|
Proceeds from issue of
common shares |
19,241 |
|
25,110 |
Transaction costs
related to issue of common shares |
(1,524) |
|
(1,702) |
Proceeds from
borrowings |
2,500 |
|
0 |
Transaction costs
related to borrowings |
(11) |
|
0 |
Repayment of
borrowings |
0 |
|
(2,250) |
Cash flow from
financing activities |
20,206 |
|
21,158 |
|
|
|
|
Exchange-rate
related changes of cash and cash equivalents |
(1,366) |
|
1,479 |
Net changes to cash
and cash equivalents |
(698) |
|
(4,240) |
Cash and cash
equivalents at the beginning of the period |
35,407 |
|
39,837 |
Cash and cash
equivalents at the end of the period |
33,343 |
|
37,076 |
Affimed N.V.Unaudited consolidated
statements of changes in equity (in € thousand)
|
|
Issued
capital |
|
Capital
reserves |
|
Fair
valuereserves |
|
Accumulated deficit |
|
Total
equity |
|
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2017 |
333 |
|
190,862 |
|
0 |
|
(152,444) |
|
38,751 |
Issue of common
shares |
114 |
|
17,199 |
|
|
|
|
|
17,313 |
Equity-settled share
based payment awards |
|
|
1,494 |
|
|
|
|
|
1,494 |
Issue of warrant note
(loan Silicon Valley Bank) |
|
|
51 |
|
|
|
|
|
51 |
Loss for the
period |
|
|
|
|
|
|
(23,802) |
|
(23,802) |
Balance as of
September 30, 2017 |
447 |
|
209,606 |
|
0 |
|
(176,246) |
|
33,807 |
|
|
|
|
|
|
|
|
|
|
Revaluation shares
Amphivena (first time adoption IFRS 9) |
|
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2018 |
468 |
|
213,778 |
|
7,325 |
|
(182,667) |
|
38,904 |
Issue of common
shares |
156 |
|
23,170 |
|
|
|
|
|
23,326 |
Exercise of share based
payments awards |
|
|
68 |
|
|
|
|
|
68 |
Equity-settled share
based payment awards |
|
|
1,523 |
|
|
|
|
|
1,523 |
Loss for the
period |
|
|
|
|
|
|
(28,237) |
|
(28,237) |
Other comprehensive
income |
|
|
|
|
264 |
|
|
|
264 |
|
|
|
|
|
|
|
|
|
|
Balance as of
September 30, 2018 |
624 |
|
238,539 |
|
7,589 |
|
(210,904) |
|
35,848 |
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