Heidelberg, Germany, March 20, 2018 - 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
and year ended December 31, 2017.
"Our approach of harnessing the power of innate
and adaptive immunity showed its first clinical potential in 2017
and early 2018 with very encouraging data becoming available for
AFM13 as monotherapy in Hodgkin and CD30-positve lymphomas as well
as for AFM13 in combination with Keytruda in Hodgkin lymphoma,"
said Dr. Adi Hoess, CEO of Affimed. "In addition, we were able to
hire outstanding executive managers with Leila Alland as CMO and
Wolfgang Fischer as COO, who will be instrumental to the further
development of our pipeline towards marketed therapies."
Corporate Updates
- In 2017 and early 2018, Affimed has made important additions to
its management team. The Company entered into an agreement with
Leila Alland, M.D. who will join Affimed as CMO effective March 26,
2018. Dr. Leila Alland brings to the Company more than 20 years of
oncology experience, having held leadership roles in drug
development at Tarveda Therapeutics, AstraZeneca, Bristol-Myers
Squibb and Novartis. Further strengthening Affimed's U.S. presence,
Dr. Alland will be based in the Company's New York location along
with Cassandra Choe-Juliak, M.D., Vice President, Clinical U.S. and
Denise Mueller, Head of Commercial Strategy and Business
Development of Affimed.
- 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 (COO).
Dr. Fischer has over 20 years of R&D experience with a focus on
oncology, immunology and pharmacology, as well as a proven track
record in drug development.
- In February 2018, Affimed completed an underwritten public
offering on the Nasdaq Global Market, raising a total of
approximately $24.5 million (€19.7 million) in net proceeds.
Proceeds from this transaction, together with existing cash on the
balance sheet, are expected to fund operations, including clinical
development and early development activities, at least until the
fourth quarter of 2019.
Pipeline Updates
NK-cell engager programs
- Enrollment has been completed into Affimed's Phase 1b
combination study of AFM13, a CD30/CD16A-targeting NK cell engager,
with Merck's Keytruda® (pembrolizumab) in relapsed/refractory
Hodgkin lymphoma (r/r HL) and treatment is ongoing. A total of 24
patients are being treated at the highest AFM13 dose level. In
February 2018, Affimed presented interim data from a total of 9
patients in this cohort, demonstrating that AFM13 in combination
with Keytruda® is well-tolerated, with a 3-month objective response
rate (ORR) of 89% comparing favorably to historical ORR of
anti-PD-1 antibodies as monotherapy in a similar patient population
(58-63%). Furthermore, 4 out of 9 patients (44%) showed complete
metabolic responses, compared to complete response rates of 9-22%
reported for anti-PD-1 monotherapy in a similar patient population.
Affimed expects full 3-month data by mid-year 2018 and intends to
provide regular updates at scientific or medical conferences.
- Affimed is supporting an investigator-sponsored 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 cutaneous
biopsies, thereby enabling assessment of NK cell biology and tumor
cell killing within the tumor microenvironment. The second cohort
has been fully enrolled and recruitment into the third cohort is
ongoing. In February 2018, the Company reported an analysis of the
first dose cohort (3 patients dosed at 1.5 mg/kg), demonstrating
that AFM13 could be safely administered and showed therapeutic
activity as a single agent, with an ORR of 66% (2 out of 3
patients). One complete response, one partial response and one
stable disease were observed, as determined by global response
score. These early data confirm the single-agent activity observed
in a previous Phase 2a trial and further suggest a new opportunity
for AFM13 in CD30-positive lymphoma.
- The Company's investigator-sponsored Phase 2a monotherapy study
of AFM13 in HL led by the German Hodgkin Study Group (GHSG) is open
and recruiting, including patients pre-treated with both
brentuximab vedotin (B.V.) and anti-PD1. In May 2017, Affimed
reported data from a subset of patients enrolled under the original
study protocol (minimum of 3 lines of treatment including B.V.,
anti-PD-1-naïve) suggesting that AFM13 is efficacious as single
agent in this heavily pre-treated group of patients.
- 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. These are intended
to be followed by a Phase 1 clinical trial.
- Affimed has generated tetravalent bispecific NK cell engager
product candidates for AFM24 (EGFR/CD16A) with different
pharmacokinetic profiles. Differentiating from current
EGFR-targeted therapeutics, the Company's molecules are designed
with the potential to widen the therapeutic window in solid tumor
therapy and to address patient populations that are resistant to
EGFR-targeting agents. Affimed anticipates completing IND-enabling
studies by mid-year 2019.
- The NK cell engager AFM26 (BCMA/CD16A), is designed to address
the medical need of eliminating minimal residual disease (MRD) in
multiple myeloma. In particular, Affimed aims to leverage BCMA as a
target in autologous stem cell transplant (ASCT)-eligible patients.
Affimed is developing different tetravalent bispecific antibody
formats and continues to advance its lead candidate in IND-enabling
studies.
- Discovering and assessing additional opportunities to harness
innate and adaptive immunity, Affimed recently published data in
Cancer Immunology Research, together with its collaboration
partner, the German Cancer Research Center (DKFZ). The Company
presented evidence of AFM13 sensitizing NK cells to IL-2 and/or
IL-15 stimulation. In this study, after exposure to AFM13, the NK
cells showed enhanced IL-2- and IL-15-mediated proliferation and
cytotoxicity. These data corroborate initial findings the Company
had presented at the AACR Annual Meeting in April 2017 and support
the approach of combining Affimed's NK cell engagers with IL-2- or
IL-15 to potentially achieve deeper clinical responses.
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 r/r acute lymphocytic leukemia (ALL)
and with r/r non-Hodgkin lymphoma (NHL), respectively. In the
Company's NHL study, the third dose cohort has recently been
completed and Affimed's ALL trial is currently recruiting patients
into the fifth dose cohort.
- Amphivena Therapeutics, Inc. continues to recruit patients into
its first-in-human Phase 1 dose escalation study of AMV564 in
r/r acute myeloid leukemia (AML). Amphivena also plans to launch a
Phase 1 clinical study in patients with myelodysplastic syndrome
(MDS) and is exploring the utility of AMV564 in solid tumors.
AMV564 is a CD33/CD3-specific T cell engagers based on Affimed's
technology platform. Affimed owns approximately 18.5% of Amphivena
(fully diluted).
Financial Highlights(Figures for the
fourth quarter of 2017 and 2016 represent unaudited figures)
Cash and cash equivalents and financial assets
totaled €39.8 million as of December 31, 2017 compared to €44.9
million as of December 31, 2016. Affimed was able to fund its
operational expenses in 2017 with existing cash, the issuance of
new shares and the usage of an additional loan tranche.
Net cash used in operating activities for the
fourth quarter of 2017 was €4.9 million compared to €6.6 million
for the fourth quarter of 2016. Net cash used in operating
activities was €25.5 million for the twelve months ended December
31, 2017 compared to €32.1 million for the twelve months ended
December 31, 2016. The year-over-year decrease was primarily
related to lower cash expenditure for research and development
(R&D) in connection with our development and collaboration
programs.
Revenue for the fourth quarter of 2017 was €0.6
million compared to €1.4 million for the fourth quarter of 2016.
Revenue for the full year 2017 was €2.0 million compared to €6.3
million for the full year 2016. Revenue for the full year and the
fourth quarter 2017 was primarily derived from AbCheck services.
Revenue for the full year 2016 related to a large extent to
Affimed's collaborations with Amphivena and LLS while revenue for
the fourth quarter 2016 was derived from AbCheck services.
R&D expenses for the fourth quarter of 2017
were €4.6 million compared to €5.7 million for the fourth quarter
of 2016. For the full year 2017, R&D expenses were €21.5
million compared to €30.2 million for the full year 2016. The
decrease was primarily related to lower expenses for AFM13 related
CMC activities, preclinical programs and infrastructure.
G&A expenses for the fourth quarter of 2017
were €1.9 million compared to €2.1 million for the fourth quarter
of 2016. For the full year 2017, G&A expenses were slightly
lower with €8.0 million compared to €8.3 million for the full year
2016.
Net loss for the fourth quarter of 2017 was €6.4
million, or €0.14 per common share, compared to a net loss of €5.4
million, or €0.19 per common share, for the fourth quarter of 2016.
Net loss for the full year 2017 was €30.2 million, or €0.69 per
common share, compared to a net loss of €32.2 million, or €0.97 per
common share, for the full year 2016. The decrease in net loss for
the full year 2017 was primarily related to decreased spending on
R&D for AFM13 related CMC activities, preclinical programs and
infrastructure, partially offset by lower revenue and higher
finance costs. Additional information regarding these results is
included in the notes to the consolidated financial statements as
of December 31, 2017 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 SEC.
Including the proceeds from the equity offering
in February 2018, the Company's operations, including clinical
development and early development activities, are expected to be
funded at least until the fourth quarter of 2019.
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
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 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.Consolidated statements of
comprehensive loss (in € thousand)
|
|
2015 |
|
2016 |
|
2017 |
Revenue |
|
7,562 |
|
6,314 |
|
2,010 |
|
|
|
|
|
|
|
Other income - net |
|
651 |
|
145 |
|
205 |
Research and
development expenses |
|
(22,008) |
|
(30,180) |
|
(21,489) |
General and
administrative expenses |
|
(7,548) |
|
(8,323) |
|
(7,986) |
|
|
|
|
|
|
|
Operating
loss |
|
(21,343) |
|
(32,044) |
|
(27,260) |
|
|
|
|
|
|
|
Finance income /
(costs) - net |
|
1,104 |
|
(230) |
|
(2,983) |
|
|
|
|
|
|
|
Loss before
tax |
|
(20,239) |
|
(32,274) |
|
(30,243) |
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
58 |
|
20 |
|
|
|
|
|
|
|
Loss for the
period |
|
(20,239) |
|
(32,216) |
|
(30,223) |
|
|
|
|
|
|
|
Total comprehensive
loss |
|
(20,239) |
|
(32,216) |
|
(30,223) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share in €
per share(undiluted = diluted) |
|
(0.71) |
|
(0.97) |
|
(0.69) |
Affimed N.V.Consolidated statements of
financial position (in € thousand)
|
December 31, 2016 |
|
December 31, 2017 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
|
|
|
|
Intangible assets |
55 |
|
65 |
Leasehold improvements
and equipment |
822 |
|
1,113 |
|
877 |
|
1,178 |
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Inventories |
197 |
|
241 |
Trade and other
receivables |
2,255 |
|
1,102 |
Other assets |
516 |
|
800 |
Financial
assets |
9,487 |
|
0 |
Cash and cash
equivalents |
35,407 |
|
39,837 |
|
47,862 |
|
41,980 |
|
|
|
|
TOTAL
ASSETS |
48,739 |
|
43,158 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
|
|
|
|
Issued capital |
333 |
|
468 |
Capital reserves |
190,862 |
|
213,778 |
Accumulated
deficit |
(152,444) |
|
(182,667) |
Total
equity |
38,751 |
|
31,579 |
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
|
Borrowings |
3,617 |
|
4,086 |
Total non-current
liabilities |
3,617 |
|
4,086 |
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Trade and other
payables |
5,323 |
|
4,180 |
Borrowings |
973 |
|
3,083 |
Deferred
revenue |
75 |
|
230 |
Total current
liabilities |
6,371 |
|
7,493 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
48,739 |
|
43,158 |
Affimed N.V.Consolidated statements of
cash flows (in € thousand)
|
2015 |
|
2016 |
|
2017 |
Cash flow from
operating activities |
|
|
|
|
|
Loss for the
period |
(20,239) |
|
(32,216) |
|
(30,223) |
Adjustments for the
period: |
|
|
|
|
|
- Income taxes |
0 |
|
(58) |
|
(20) |
- Depreciation and
amortization |
336 |
|
369 |
|
351 |
- Net gain from
disposal of leasehold improvements and equipment |
0 |
|
0 |
|
(19) |
- Share based
payments |
2,220 |
|
3,545 |
|
1,943 |
- Finance income /
costs - net |
(1,104) |
|
230 |
|
2,983 |
|
(18,787) |
|
(28,130) |
|
(24,985) |
Change in trade and
other receivables |
24 |
|
(1,311) |
|
1,140 |
Change in
inventories |
(29) |
|
31 |
|
(44) |
Change in other
assets |
(452) |
|
(64) |
|
(399) |
Change in trade, other
payables and deferred revenue |
1,253 |
|
(2,177) |
|
(1,018) |
Cash used in operating
activities |
(17,991) |
|
(31,651) |
|
(25,306) |
Interest received |
10 |
|
102 |
|
106 |
Paid interest |
(554) |
|
(578) |
|
(349) |
Net cash used in
operating activities |
(18,535) |
|
(32,127) |
|
(25,549) |
Cash flow from
investing activities |
|
|
|
|
|
Purchase of intangible
assets |
(28) |
|
(21) |
|
(43) |
Purchase of leasehold
improvements and equipment |
(249) |
|
(238) |
|
(625) |
Cash received from the
sale of leasehold improvements and equipment |
0 |
|
0 |
|
35 |
Cash paid for
investments in convertible note and warrants |
0 |
|
0 |
|
(296) |
Cash paid for
investments in financial assets |
0 |
|
(27,037) |
|
(13,084) |
Cash received from
maturity of financial assets |
0 |
|
18,147 |
|
22,063 |
Net cash used for
investing activities |
(277) |
|
(9,149) |
|
8,050 |
Cash flow from
financing activities |
|
|
|
|
|
Proceeds from issue of
common shares |
56,615 |
|
6 |
|
23,123 |
Transaction costs
related to issue of common shares |
(3,117) |
|
0 |
|
(1,648) |
Proceeds from
borrowings |
0 |
|
5,000 |
|
2,500 |
Transaction costs
related to borrowings |
0 |
|
(105) |
|
(11) |
Repayment of
borrowings |
0 |
|
(5,137) |
|
(167) |
Cash flow from
financing activities |
53,498 |
|
(236) |
|
23,797 |
Exchange-rate
related changes of cash and cash equivalents |
2,329 |
|
179 |
|
(1,867) |
Net changes to cash
and cash equivalents |
34,686 |
|
(41,512) |
|
6,297 |
Cash and cash
equivalents at the beginning of the period |
39,725 |
|
76,740 |
|
35,407 |
Cash and cash
equivalents at the end of the period |
76,740 |
|
35,407 |
|
39,837 |
Affimed N.V.Consolidated statements of
changes in equity (in € thousand)
|
Issued
capital |
|
Capital
reserves |
|
|
Accumulated deficit |
|
Total equity |
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2015 |
240 |
|
131,544 |
|
|
(99,989) |
|
31,795 |
Issue of common
shares |
91 |
|
52,463 |
|
|
|
|
52,554 |
Exercise of share based
payment awards |
2 |
|
942 |
|
|
|
|
944 |
Equity-settled share
based payment award |
|
|
2,220 |
|
|
|
|
2,220 |
Loss for period |
|
|
|
|
|
(20,239) |
|
(20,239) |
Balance as of
December 31, 2015 |
333 |
|
187,169 |
|
|
(120,228) |
|
67,274 |
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2016 |
333 |
|
187,169 |
|
|
(120,228) |
|
67,274 |
Issue of common
shares1 |
0 |
|
6 |
|
|
|
|
6 |
Equity-settled share
based payment awards |
|
|
3,545 |
|
|
|
|
3,545 |
Issue of warrant note
(loan Silicon Valley Bank) |
|
|
142 |
|
|
|
|
142 |
Loss for the
period |
|
|
|
|
|
(32,216) |
|
(32,216) |
Balance as of
December 31, 2016 |
333 |
|
190,862 |
|
|
(152,444) |
|
38,751 |
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2017 |
333 |
|
190,862 |
|
|
(152,444) |
|
38,751 |
Issue of common
shares |
135 |
|
20,922 |
|
|
|
|
21,057 |
Equity-settled share
based payment awards |
|
|
1,943 |
|
|
|
|
1,943 |
Issue of warrant note
(loan Silicon Valley Bank) |
|
|
51 |
|
|
|
|
51 |
Loss for the
period |
|
|
|
|
|
(30,223) |
|
(30,223) |
Balance as of
December 31, 2017 |
468 |
|
213,778 |
|
|
(182,667) |
|
31,579 |
1 Issue of 3,341 shares
Affimed N.V.Consolidated statements of
comprehensive loss (in € thousand)
|
|
Q4 2016(unaudited) |
|
Q4
2017(unaudited) |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
1,371 |
|
636 |
|
|
|
|
|
Other income - net |
|
2 |
|
4 |
Research and
development expenses |
|
(5,724) |
|
(4,608) |
General and
administrative expenses |
|
(2,084) |
|
(1,895) |
|
|
|
|
|
Operating
(loss) |
|
(6,435) |
|
(5,863) |
|
|
|
|
|
Finance income /
(costs) - net |
|
953 |
|
(558) |
|
|
|
|
|
Loss before
tax |
|
(5,482) |
|
(6,421) |
|
|
|
|
|
Income taxes |
|
60 |
|
0 |
|
|
|
|
|
Loss for the
period |
|
(5,422) |
|
(6,421) |
|
|
|
|
|
Total comprehensive
loss |
|
(5,422) |
|
(6,421) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share in €
per share |
|
(0.19) |
|
(0.14) |
(undiluted =
diluted) |
|
|
|
|
Affimed N.V.Consolidated statements of
cash flows (in € thousand)
|
|
Q4
2016(unaudited) |
|
Q4
2017(unaudited) |
Cash flow from
operating activities |
|
|
|
|
Loss for the
period |
|
(5,422) |
|
(6,421) |
Adjustments for the
period: |
|
|
|
|
- Income taxes |
|
(60) |
|
0 |
- Depreciation and
amortization |
|
76 |
|
94 |
- Share based
payments |
|
826 |
|
449 |
- Finance income /
costs - net |
|
(953) |
|
558 |
|
|
|
|
|
|
|
(5,533) |
|
(5,320) |
Change in trade and
other receivables |
|
87 |
|
450 |
Change in
inventories |
|
56 |
|
41 |
Change in other
assets |
|
87 |
|
(6) |
Change in trade, other
payables and deferred revenue |
|
(1,097) |
|
26 |
|
|
|
|
|
Cash used in operating
activities |
|
(6,400) |
|
(4,809) |
Interest received |
|
42 |
|
58 |
Paid interest |
|
(223) |
|
(120) |
Net cash used in
operating activities |
|
(6,581) |
|
(4,871) |
|
|
|
|
|
Cash flow from
investing activities |
|
|
|
|
Purchase of intangible
assets |
|
0 |
|
(17) |
Purchase of leasehold
improvements and equipment |
|
(44) |
|
(80) |
Cash paid for
investments in convertible note and warrants |
|
0 |
|
(296) |
Cash paid for
investments in financial assets |
|
51 |
|
30 |
Cash received from
maturity of financial assets |
|
4,611 |
|
8,638 |
Net cash used for
investing activities |
|
4,618 |
|
8,275 |
|
|
|
|
|
Cash flow from
financing activities |
|
|
|
|
Proceeds from issue of
common shares |
|
6 |
|
3,882 |
Transaction costs
related to issue of common shares |
|
0 |
|
(124) |
Proceeds from
borrowings |
|
5,000 |
|
0 |
Transaction costs
related to borrowings |
|
(105) |
|
0 |
Repayment of
borrowings |
|
(4,058) |
|
(167) |
Cash flow from
financing activities |
|
843 |
|
3,591 |
|
|
|
|
|
Exchange-rate
related changes of cash and cash equivalents |
|
834 |
|
(501) |
Net changes to cash
and cash equivalents |
|
(1,120) |
|
6,995 |
Cash and cash
equivalents at the beginning of the period |
|
35,693 |
|
33,343 |
Cash and cash
equivalents at the end of the period |
|
35,407 |
|
39,837 |
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