Heidelberg, Germany, November 7, 2017 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
focused on discovering and developing highly targeted cancer
immunotherapies, today reported financial results for the quarter
ended September 30, 2017.
"We continue to make great strides in validating
our NK cell engager programs, in particular through encouraging
data from studies of our lead candidate AFM13, which is progressing
through clinical development as a mono- and combination therapy,"
said Dr. Adi Hoess, CEO of Affimed. "Leveraging our unique NK
cell-based platform for high-affinity CD16A-targeting, we are
advancing our tetravalent bispecific antibodies with the potential
to tailor immune-engaging therapy to different indications and
settings."
Third Quarter Updates
Corporate Update
- In September 2017, Dr. Wolfgang Fischer, former Global Head of
Program and Project Management of Sandoz Biopharmaceuticals
(Novartis Group) joined Affimed as Chief Operating Officer. Dr.
Fischer has over 20 years of R&D experience with a focus on
oncology, immunology and pharmacology. With his proven track record
in drug development, he will support the Company in advancing its
unique immune cell engagers to address the existing medical need in
hematologic and solid tumor indications. In addition to his role as
COO, Dr. Fischer will assume responsibility as interim CMO, working
closely with the Company's clinical team.
NK cell engager programs
- In Affimed's Phase 1b combination study of its lead product
candidate, the CD30/CD16A-targeting NK cell engager AFM13, with
Merck's Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) the dose
expansion cohort is open and recruiting. Data analysis of
three-month response rates is ongoing for the escalation phase of
the trial with analysis of 9 out of 12 patients completed to date.
Of the 3 patients enrolled into cohort 1, two experienced partial
metabolic responses, while one patient progressed. Of the 3
patients enrolled into cohort 2, one patient experienced a complete
metabolic response, one patient experienced a partial metabolic
response and one patient progressed. Out of the six patients in
dose cohort 3, three were analyzed to date, all of which
experienced partial metabolic responses at the first tumor response
assessment. The Company intends to present detailed dose escalation
data including response data of the three remaining patients in
cohort 3 at the upcoming ASH 2017 Annual Meeting in December.
- Affimed is supporting a translational Phase 1b/2a study of
AFM13 in patients with relapsed or refractory CD30-positive
lymphoma with cutaneous manifestation led by Columbia University.
The study is designed to allow for serial biopsies, thereby
enabling assessment of NK cell biology and tumor cell killing
within the tumor microenvironment. The first cohort has been fully
enrolled and recruitment into further cohorts is ongoing. The first
patient, suffering from anaplastic large-cell lymphoma (ALCL) with
cutaneous manifestation, experienced a complete response of
cutaneous lesions after the first treatment cycle. Systemic
evaluation is ongoing. This provides first evidence that NK cell
engagers are able to induce tumor regression in this
indication.
- The Company's investigator-sponsored Phase 2a monotherapy study
of AFM13 in HL led by the German Hodgkin Study Group (GHSG), is
open to recruit under the new design, which includes patients
pre-treated with both brentuximab vedotin (B.V.) and anti-PD1.
- In Affimed's collaboration with The University of Texas MD
Anderson Cancer Center (MDACC), evaluating the Company's NK cell
engager AFM13 in combination with MDACC's NK cell product,
preclinical research activities are progressing.
- The Company has developed multiple tetravalent, bispecific
antibody formats in addition to its TandAbs. These molecules confer
distinct biophysical properties aimed at tailoring PK profiles.
Based on its platform, Affimed is advancing AFM24, an
EGFR/CD16A-specific NK cell engager and AFM26, a
BCMA/CD16A-specific NK cell engager, through IND-enabling studies.
Final candidates have been selected for AFM24 and AFM26,
respectively.
- Candidates for AFM24, developed to treat solid tumors, are
based on both TandAb format and on novel proprietary antibody
formats. AFM24 molecules offer a differentiated mode of action as
compared to cetuximab. Furthermore, binding to NK cells is largely
unaffected by IgG competition, resulting in higher efficacy and
elimination of cells with low target expression. Affimed is
currently evaluating its novel format-based AFM24 molecules, which
have significantly longer half-lives, in comparison to the
Company's TandAbs, which have already shown evidence of a
beneficial safety profile.
- AFM26 is designed to eliminate malignant cells in multiple
myeloma (MM) independent of BCMA expression levels. AFM26 offers a
differentiated mode of action, targeting cells expressing very low
levels of BCMA, conferring NK cell cytotoxicity and eliciting lower
cytokine release compared to a BiTE molecule. Furthermore, binding
to NK cells is largely unaffected by IgG competition. These unique
features could position AFM26 in patients receiving autologous stem
cell transplant (ASCT)-eligible at or shortly after transplant, a
period in which no treatment is currently available.
T cell engager programs
- Affimed is conducting two clinical Phase 1 dose-escalation
trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T
cell engager in patients with relapsed and refractory (r/r) acute
lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL),
respectively. Both studies are ongoing and recruiting.
- Recruitment is ongoing into a first-in-human Phase 1 dose
escalation trial of AMV564 conducted by Amphivena Therapeutics,
Inc. in patients with r/r acute myeloid leukemia (AML). AMV564 is a
CD33/CD3-specific antibody based on Affimed's technology platform.
Affimed owns ~18.5% of Amphivena (fully diluted).
Financial Highlights(Figures for the
third quarter and first nine months of 2017 and 2016 represent
unaudited figures)
Cash and cash equivalents and financial assets totaled €41.8
million as of September 30, 2017 compared to €44.9 million as of
December 31, 2016. Affimed's operational expenses for the nine
months ended September 30, 2017 were primarily offset by net
proceeds of €16.4 million from a public offering of common shares
in the first quarter and of €2.5 million from the drawdown of the
second tranche of the loan from Silicon Valley Bank.
Net cash used in operating activities was €20.7 million for the
nine months ended September 30, 2017 compared to €25.5 million for
the nine months ended September 30, 2016. The decrease was
primarily related to lower cash expenditure for research and
development (R&D) in connection with Affimed's development and
collaboration programs and to the expiration of the Amphivena
collaboration.
Revenue for the third quarter of 2017 was €0.5 million compared
to €0.9 million for the third quarter of 2016. Revenue in the 2017
period was derived from AbCheck services while revenue in the 2016
period related predominantly to Affimed's collaboration with
Amphivena.
R&D expenses for the third quarter of 2017 were €6.0 million
compared to €8.8 million for the third quarter of 2016. The
decrease was primarily related to lower expenses for AFM13 and our
discovery/early stage development activities.
G&A expenses for the third quarter of 2017 were €1.9 million
compared to €2.2 million for the third quarter of 2016.
Net loss for the third quarter of 2017 was €8.1 million, or
€0.18 per common share, compared to a net loss of €10.3 million, or
€0.31 per common share, for the third quarter of 2016. The decrease
of operating expenses was partially offset by lower revenue and
higher finance costs.
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's management will host a conference call to
discuss the company's financial results and recent corporate
developments today at 8:30 a.m. ET. A webcast of the conference
call can be accessed in the "Events" section on the "Investors
& Media" page of the Affimed website at
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 on the Affimed website 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 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,
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.
Contact:Anca Alexandru, Head of
Communications, EU IRPhone: +49 6221 64793341E-Mail:
a.alexandru@affimed.com, IR@affimed.com
AFFIMED N.V.CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
Affimed N.V.Unaudited condensed
consolidated statements of comprehensive loss (in €
thousand)
|
For the three-months ended September 30 |
|
For the nine-months ended September 30 |
|
|
2016 |
|
2017 |
|
2016 |
|
2017 |
Revenue |
|
938 |
|
467 |
|
4,943 |
|
1,374 |
|
|
|
|
|
|
|
|
|
Other income - net |
|
19 |
|
117 |
|
143 |
|
201 |
Research and
development expenses |
|
(8,760) |
|
(6,008) |
|
(24,456) |
|
(16,881) |
General and
administrative expenses |
|
(2,181) |
|
(1,876) |
|
(6,239) |
|
(6,091) |
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(9,984) |
|
(7,300) |
|
(25,609) |
|
(21,397) |
|
|
|
|
|
|
|
|
|
Finance income /
(costs) - net |
|
(311) |
|
(800) |
|
(1,183) |
|
(2,425) |
|
|
|
|
|
|
|
|
|
Loss before
tax |
|
(10,295) |
|
(8,100) |
|
(26,792) |
|
(23,822) |
|
|
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
0 |
|
(2) |
|
20 |
|
|
|
|
|
|
|
|
|
Loss for the
period |
|
(10,295) |
|
(8,100) |
|
(26,794) |
|
(23,802) |
|
|
|
|
|
|
|
|
|
Total comprehensive
loss |
|
(10,295) |
|
(8,100) |
|
(26,794) |
|
(23,802) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share in €
per share(undiluted = diluted) |
|
(0.31) |
|
(0.18) |
|
(0.81) |
|
(0.55) |
Affimed N.V.Condensed consolidated
statements of financial position (in € thousand)
|
December 31, 2016 |
|
September 30, 2017 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
Non-current assets |
|
|
|
|
|
|
|
Intangible assets |
55 |
|
56 |
Leasehold improvements and equipment |
822 |
|
1,120 |
|
877 |
|
1,176 |
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Inventories |
197 |
|
282 |
Trade
and other receivables |
2,255 |
|
1,583 |
Other
assets |
516 |
|
502 |
Financial assets |
9,487 |
|
8,470 |
Cash and
cash equivalents |
35,407 |
|
33,343 |
|
47,862 |
|
44,180 |
|
|
|
|
TOTAL
ASSETS |
48,739 |
|
45,356 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Equity |
|
|
|
|
|
|
|
Issued
capital |
333 |
|
447 |
Capital
reserves |
190,862 |
|
209,606 |
Accumulated deficit |
(152,444) |
|
(176,246) |
Total
equity |
38,751 |
|
33,807 |
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
Borrowings |
3,617 |
|
4,682 |
Total
non-current liabilities |
3,617 |
|
4,682 |
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Trade
and other payables |
5,323 |
|
4,334 |
Borrowings |
973 |
|
2,500 |
Deferred
revenue |
75 |
|
33 |
Total
current liabilities |
6,371 |
|
6,867 |
|
|
|
|
TOTAL
EQUITY AND LIABILITIES |
48,739 |
|
45,356 |
Affimed N.V.Unaudited condensed
consolidated statements of cash flows (in € thousand)
|
For the nine-months ended September 30 |
|
2016 |
|
2017 |
Cash flow from
operating activities |
|
|
|
Loss for the
period |
(26,794) |
|
(23,802) |
Adjustments for the
period: |
|
|
|
- Income taxes |
2 |
|
(20) |
- Depreciation and
amortization |
293 |
|
257 |
- Gain from disposal of
leasehold improvements and equipment |
0 |
|
(20) |
- Share based
payments |
2,719 |
|
1,494 |
- Finance income /
costs - net |
1,183 |
|
2,425 |
|
(22,597) |
|
(19,666) |
Change in trade and
other receivables |
(1,398) |
|
690 |
Change in
inventories |
(25) |
|
(85) |
Change in other
assets |
(151) |
|
(393) |
Change in trade, other
payables and deferred revenue |
(1,080) |
|
(1,044) |
Cash used in operating
activities |
(25,251) |
|
(20,498) |
Interest received |
60 |
|
48 |
Paid interest |
(355) |
|
(229) |
Net cash used in
operating activities |
(25,546) |
|
(20,679) |
|
|
|
|
Cash flow from
investing activities |
|
|
|
Purchase of intangible
assets |
(21) |
|
(26) |
Purchase of leasehold
improvements and equipment |
(194) |
|
(545) |
Cash received from the
sale of leasehold improvements and equipment |
0 |
|
35 |
Cash paid for
investments in financial assets |
(27,088) |
|
(13,114) |
Cash received from
maturity of financial assets |
13,536 |
|
13,425 |
Net cash used for
investing activities |
(13,767) |
|
(225) |
|
|
|
|
Cash flow from
financing activities |
|
|
|
Proceeds from issue of
common shares |
0 |
|
19,241 |
Transaction costs
related to issue of common shares |
0 |
|
(1,524) |
Proceeds from
borrowings |
0 |
|
2,500 |
Transaction costs
related to borrowings |
0 |
|
(11) |
Repayment of
borrowings |
(1,079) |
|
0 |
Cash flow from
financing activities |
(1,079) |
|
20,206 |
|
|
|
|
Net changes to cash
and cash equivalents |
(40,392) |
|
(698) |
Cash and cash
equivalents at the beginning of the period |
76,740 |
|
35,407 |
Exchange-rate
related changes of cash and cash equivalents |
(655) |
|
(1,366) |
Cash and cash
equivalents at the end of the period |
35,693 |
|
33,343 |
Affimed N.V.Unaudited condensed
consolidated statements of changes in equity (in €
thousand)
|
Issued
capital |
|
Capital
reserves |
|
Accumulated deficit |
|
Total Equity |
|
|
|
|
|
|
|
|
Balance as of
January 1, 2016 |
333 |
|
187,169 |
|
(120,228) |
|
67,274 |
Equity-settled share
based payment awards |
|
|
2,719 |
|
|
|
2,719 |
Loss for the
period |
|
|
|
|
(26,794) |
|
(26,794) |
|
|
|
|
|
|
|
|
Balance as of
September 30, 2016 |
333 |
|
189,888 |
|
(147,022) |
|
43,199 |
|
|
|
|
|
|
|
|
Balance as of
January 1, 2017 |
333 |
|
190,862 |
|
(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 |
|
(176,246) |
|
33,807 |
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Apr 2023 to Apr 2024