Heidelberg, Germany, August 1, 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 June 30, 2017.
"We are encouraged by the progress of our
clinical programs, in particular moving into the expansion phase of
our AFM13 combination trial with Keytruda," said Dr. Adi Hoess, CEO
of Affimed. "In our preclinical programs addressing the medical
need in solid tumors and multiple myeloma, we have designed and
characterized well-differentiated molecules and determined
advantages in safety and potency."
Second Quarter Updates
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
Keytruda (pembrolizumab) in Hodgkin lymphoma (HL), the Company has
completed the escalation phase and initiated the dose expansion
cohort. Affimed continues to anticipate providing an update on the
study in the second half of 2017.
- The Company's investigator-sponsored Phase 2a monotherapy study
of AFM13 in HL led by the German Hodgkin Study Group (GHSG), is now
open to recruit under the new design, which includes patients
pre-treated with both brentuximab vedotin (B.V.) and anti-PD1.
Affimed intends to present full data on the study upon its
completion, which is anticipated in 2019. The Company may provide
prior data updates in coordination with the GHSG.
- Columbia University has recently initiated a translational
Phase 1b/2a study to evaluate AFM13 in patients with relapsed or
refractory CD30-positive lymphoma with cutaneous manifestation.
Affimed is supporting this trial, which is designed to allow for
serial biopsies, thereby enabling assessment of NK cell biology and
tumor cell killing within the tumor microenvironment.
- Preclinical research activities are progressing in Affimed's
collaboration with The University of Texas MD Anderson Cancer
Center (MDACC) evaluating the Company's NK cell engager technology
in combination with MDACC's NK cell product. Affimed intends to
provide regular progress updates on the collaboration.
- In June 2017, Affimed presented data at the EACR-AACR-SIC
Special Conference in Florence, Italy, on its EGFR-targeting NK
cell engager AFM24. AFM24 is distinguished from cetuximab both in
vitro and in vivo through higher potency at both high and low EGFR
expression levels and in RAS mutant cells. In addition, the NK cell
engager potentially offers a more favorable safety profile, as
demonstrated in single and repeated-dose toxicity pilot studies in
cynomolgus monkeys. AFM24 was well-tolerated and showed no evidence
of skin toxicity, a side effect commonly seen for other
EGFR-targeting therapeutics. Affimed has developed multiple
tetravalent, bispecific antibody formats for EGFR/CD16A-specific NK
cell engagers aimed at tailoring PK profiles. Final clinical
candidates have been selected and the Company is currently
evaluating which candidate it will move forward through
IND-enabling studies.
- Affimed presented data on AFM26, a B-cell maturation antigen
(BCMA)-targeting tetravalent bispecific NK cell engager at the ASCO
Annual Meeting in Chicago, IL and at the EACR-AACR-SIC Special
Conference, both in June 2017. The data highlighted AFM26's
potential to overcome the challenge to eliminate malignant cells in
multiple myeloma (MM), including in cells expressing very low
levels of BCMA. In particular, the data demonstrated that through
its unique properties, including enhanced avidity, resilience to
serum IgG competition and improved cell surface retention, AFM26
elicited a more potent target cell lysis compared to daratumumab
and elotuzumab while not inducing NK cell depletion. Compared to a
BCMA-specific T cell engager (BiTE), AFM26, while effectively
lysing target cells, elicited substantially lower cytokine release,
indicating a potentially superior safety profile. The data also
highlighted AFM26 as a promising first-in-class therapeutic with
potential in autologous stem cell transplant (ASCT)-eligible
patients. The Company is currently evaluating which candidate it
will move forward through IND-enabling studies.
T cell engager programs
- Affimed is conducting two clinical Phase 1 dose-escalation
trials of its CD19-targeting tetravalent bispecific T cell engager
AFM11 in patients with relapsed and refractory (r/r) acute
lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL),
respectively. Both studies, which are designed with accelerated
titration followed by a classical 3+3 design, are ongoing and
recruiting.
- The study evaluating AFM11 in ALL patients was initiated in
September 2016 and 12 sites in the Czech Republic, Poland, Russia,
Austria and Israel are open. Patients are currently being recruited
into the fourth dose cohort. AFM11 was overall well-tolerated and
no DLTs were observed in dose cohorts 1-3. The Company intends to
provide updates on the study on a regular basis.
- In Affimed's Phase 1 trial of AFM11 in patients with NHL, which
was amended in May 2016, the number of trial sites has been
significantly increased in the course of the study. 10 sites are
now open and recruiting in the Czech Republic, Poland, Germany and
the U.S. The study is currently recruiting patients into the third
dose cohort under the revised study design. In these patients,
AFM11 was overall well-tolerated and no DLTs were observed in the
first two cohorts. The Company intends to provide updates on the
study on a regular basis.
- Amphivena Therapeutics, Inc. continues recruitment into its
first-in-human Phase 1 dose escalation and expansion trial of
AMV564, a CD33/CD3-specific antibody based on Affimed's technology
platform, in patients with r/r acute myeloid leukemia (AML).
Affimed owns ~18.5% of Amphivena (fully diluted).
Financial Highlights
(Figures for the second quarter and six months
of 2017 and 2016 represent unaudited figures)
Cash and cash equivalents and financial assets
totaled €48.9 million as of June 30, 2017 compared to €44.9 million
as of December 31, 2016. The increase was primarily attributable to
the 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, largely
offset by operational expenses.
Net cash used in operating activities was €13.1
million for the six months ended June 30, 2017 compared to €17.0
million for the six months ended June 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 second quarter of 2017 was €0.5
million compared to €2.1 million for the second quarter of 2016.
Revenue in the 2017 period was primarily derived from AbCheck
services while revenue in the 2016 period relates predominantly to
Affimed's collaboration with Amphivena.
R&D expenses for the second quarter of 2017
were €5.4 million compared to €8.6 million for the second 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 second quarter of 2017
were unchanged at €2.0 million compared the second quarter of
2016.
Net loss for the second quarter of 2017 was €7.9 million, or
€0.18 per common share, compared to a net loss of €8.0 million, or
€0.24 per common share, for the second quarter of 2016. The
decrease of operating expenses was offset by lower revenue. In
addition, the result was affected by finance costs of €1.2 million
in the second quarter of 2017, whereas finance income of €0.5
million was shown in the second quarter of 2016.
Note on IFRS Reporting Standards
Affimed 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 information
Affimed'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 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, 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.
IR Contact:
Caroline Stewart, Head IRPhone: +1 347394 6793E-Mail:
IR@affimed.com or c.stewart@affimed.com
Media Contact:
Anca Alexandru, Head of Communications, EU IRPhone: +49 6221
64793341E-Mail: a.alexandru@affimed.com
AFFIMED N.V.CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Affimed N.V.Unaudited condensed consolidated statement
of comprehensive loss (in € thousand)
|
|
For the three months ended June 30 |
|
For the six months ended June 30 |
|
|
2016 |
|
2017 |
|
2016 |
|
2017 |
Revenue |
|
2,069 |
|
508 |
|
4,005 |
|
907 |
|
|
|
|
|
|
|
|
|
Other income - net |
|
38 |
|
93 |
|
124 |
|
84 |
Research and
development expenses |
|
(8,628) |
|
(5,431) |
|
(15,696) |
|
(10,873) |
General and
administrative expenses |
|
(1,965) |
|
(1,969) |
|
(4,058) |
|
(4,215) |
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(8,486) |
|
(6,799) |
|
(15,625) |
|
(14,097) |
|
|
|
|
|
|
|
|
|
Finance income /
(costs) - net |
|
450 |
|
(1,169) |
|
(872) |
|
(1,625) |
|
|
|
|
|
|
|
|
|
Loss before
tax |
|
(8,036) |
|
(7,968) |
|
(16,497) |
|
(15,722) |
|
|
|
|
|
|
|
|
|
Income taxes |
|
(1) |
|
21 |
|
(2) |
|
20 |
|
|
|
|
|
|
|
|
|
Loss for the
period |
|
(8,037) |
|
(7,947) |
|
(16,499) |
|
(15,702) |
|
|
|
|
|
|
|
|
|
Total comprehensive
loss |
|
(8,037) |
|
(7,947) |
|
(16,499) |
|
(15,702) |
|
|
|
|
|
|
|
|
|
Loss per share in €
per share(undiluted = diluted) |
|
(0.24) |
|
(0.18) |
|
(0.50) |
|
(0.37) |
Affimed N.V.Condensed consolidated statement of
financial position (in € thousand)
|
December 31, 2016 |
|
June
30, 2017 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
|
|
|
|
Intangible assets |
55 |
|
61 |
Leasehold improvements
and equipment |
822 |
|
1,004 |
|
877 |
|
1,065 |
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Inventories |
197 |
|
250 |
Trade and other
receivables |
2,255 |
|
2,524 |
Other assets |
516 |
|
513 |
Financial
assets |
9,487 |
|
4,381 |
Cash and cash
equivalents |
35,407 |
|
44,486 |
|
47,862 |
|
52,154 |
|
|
|
|
TOTAL
ASSETS |
48,739 |
|
53,219 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
|
|
|
|
Issued capital |
333 |
|
439 |
Capital reserves |
190,862 |
|
207,841 |
Accumulated
deficit |
(152,444) |
|
(168,146) |
Total
equity |
38,751 |
|
40,134 |
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
|
Borrowings |
3,617 |
|
5,284 |
Total non-current
liabilities |
3,617 |
|
5,284 |
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Trade and other
payables |
5,323 |
|
5,793 |
Borrowings |
973 |
|
1,750 |
Deferred
revenue |
75 |
|
258 |
Total current
liabilities |
6,371 |
|
7,801 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
48,739 |
|
53,219 |
Affimed N.V.Unaudited condensed consolidated statement
of cash flows (in € thousand)
|
For the six month ended June 30 |
|
2016 |
|
2017 |
Cash flow from
operating activities |
|
|
|
Loss for the
period |
(16,499) |
|
(15,702) |
Adjustments for the
period: |
|
|
|
- Income taxes |
2 |
|
(20) |
- Depreciation and
amortization |
193 |
|
169 |
- Gain from disposal of
leasehold improvements and equipment |
0 |
|
(20) |
- Share based
payments |
1,785 |
|
1,018 |
- Finance income /
costs - net |
872 |
|
1,625 |
|
(13,647) |
|
(12,930) |
Change in trade and
other receivables |
(183) |
|
(250) |
Change in
inventories |
(5) |
|
(53) |
Change in other
assets |
(230) |
|
(404) |
Change in trade, other
payables and deferred revenue |
(2,667) |
|
657 |
Cash used in operating
activities |
(16,732) |
|
(12,980) |
Interest received |
0 |
|
25 |
Paid interest |
(246) |
|
(128) |
Net cash used in
operating activities |
(16,978) |
|
(13,083) |
|
|
|
|
Cash flow from
investing activities |
|
|
|
Purchase of intangible
assets |
(11) |
|
(23) |
Purchase of leasehold
improvements and equipment |
(157) |
|
(349) |
Cash received from the
sale of leasehold improvements and equipment |
0 |
|
18 |
Cash paid for
investments in financial assets |
(18,128) |
|
(4,655) |
Cash received from
maturity of financial assets |
0 |
|
9,209 |
Net cash used for
investing activities |
(18,296) |
|
4,200 |
|
|
|
|
Cash flow from
financing activities |
|
|
|
Proceeds from issue of
common shares |
0 |
|
17,901 |
Transaction costs
related to issue of common shares |
0 |
|
(1,481) |
Proceeds from
borrowings |
0 |
|
2,500 |
Transaction costs
related to borrowings |
0 |
|
(11) |
Repayment of
borrowings |
(357) |
|
0 |
Cash flow from
financing activities |
(357) |
|
18,909 |
|
|
|
|
Net changes to cash
and cash equivalents |
(35,631) |
|
10,026 |
Cash and cash
equivalents at the beginning of the period |
76,740 |
|
35,407 |
Exchange-rate
related changes of cash and cash equivalents |
(506) |
|
(947) |
Cash and cash
equivalents at the end of the period |
40,603 |
|
44,486 |
Affimed N.V.Unaudited condensed consolidated statement
of changes in equity (in € thousand)
|
Issued
capital |
|
Capital
reserves |
|
Accumulated deficit |
|
Totalequity |
|
|
|
|
|
|
|
|
Balance as of
January 1, 2016 |
333 |
|
187,169 |
|
(120,228) |
|
67,274 |
Equity-settled share
based payment awards |
|
|
1,785 |
|
|
|
1,785 |
Loss for the
period |
|
|
|
|
(16,499) |
|
(16,499) |
|
|
|
|
|
|
|
|
Balance as of June
30, 2016 |
333 |
|
188,954 |
|
(136,727) |
|
52,560 |
|
|
|
|
|
|
|
|
Balance as of
January 1, 2017 |
333 |
|
190,862 |
|
(152,444) |
|
38,751 |
Issue of common
shares |
106 |
|
15,910 |
|
|
|
16,016 |
Equity-settled share
based payment awards |
|
|
1,018 |
|
|
|
1,018 |
Issue of warrant note
(loan Silicon Valley Bank) |
|
|
51 |
|
|
|
51 |
Loss for the
period |
|
|
|
|
(15,702) |
|
(15,702) |
|
|
|
|
|
|
|
|
Balance as of June
30, 2017 |
439 |
|
207,841 |
|
(168,146) |
|
40,134 |
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