Heidelberg, Germany, November 2, 2016 - 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, 2016.
"During the third quarter of 2016 we have made
considerable progress in both clinical and preclinical development
of our immune cell engagers," said Dr. Adi Hoess, CEO of Affimed.
"We are continuously advancing our lead NK-cell engager AFM13 in
combination therapy and have enrolled the first patient into an ALL
trial for our T-cell engager AFM11. Through our preclinical
activities in solid tumor indications and multiple myeloma, we
continue to pursue novel opportunities for our bi- and trispecific
NK-cell engagers."
Third Quarter Highlights
NK-cell engager programs
- Affimed's Phase 1b combination study of AFM13, a CD30/CD16A
TandAb, with Keytruda® (pembrolizumab) in Hodgkin lymphoma (HL) is
ongoing and now recruiting into the second dose cohort. The Company
intends to provide a first update on the study by the end of 2016
or first quarter of 2017.
- In the Phase 2a monotherapy trial for AFM13 in HL sponsored by
the German Hodgkin Study Group (GHSG), Affimed is working with the
sponsor to revise the study protocol, and anticipates providing an
update on the revised in- and exclusion criteria and overall study
design by the end of 2016. The study remains open and recruiting
under the original study protocol to gain insights into specific
patient subsets.
- Affimed intends to conduct a Company-sponsored trial for AFM13
in CD30-positive lymphoma, including T-cell lymphoma (TCL). Affimed
plans to integrate translational aspects of the Phase 1b/2a study
in CD30-positive lymphoma with cutaneous manifestation into this
trial that previously had been planned as an investigator-sponsored
translational trial to be led by Columbia University.
- The Company has decided to advance AFM24, an EGFRwt/CD16A
TandAb, in solid tumors and has selected a development candidate
for AFM24 in indications such as lung, head and neck and colon
cancers. In vitro, AFM24 has shown higher antigen-specific
cytotoxic activity compared to cetuximab, including in cells
expressing the proto-oncogene ras. Preclinical toxicity evaluation
is ongoing and Affimed intends to provide an update on the AFM24
program in the first half of 2017.
- In its discovery program for multiple myeloma (MM), Affimed is
developing AFM26, a bispecific molecule targeting BCMA/CD16A. MM is
characterized by very high serum levels of M-protein, which
consists of immunoglobulins produced by an excess of plasma cells
in MM patients. In line with results from the Company's other
NK-cell TandAbs, AFM26 displays very strong in vitro
antigen-specific cytotoxicity, with NK-cell binding even in the
presence of high levels of IgG. Preclinical investigations are
ongoing. In addition to this program, Affimed is pursuing a
trispecific approach to treat MM, with molecules designed to bind
various tumor-specific targets including BCMA.
T-cell engager programs
- The Company has initiated a Phase 1 dose-escalation trial of
its CD19/CD3 TandAb AFM11 in patients with relapsed and refractory
acute lymphocytic leukemia (ALL) and has enrolled the first
patient. The study is being conducted in Eastern Europe, Russia and
Israel.
- Recruitment into Affimed's Phase 1 study in non-Hodgkin
lymphoma (NHL) for AFM11 is slower than expected and the Company
has responded to this by initiating new trial sites in Eastern
Europe and the U.S. Affimed no longer expects to present data by
year end and intends to provide an update on the study timelines in
the first half of 2017.
- Amphivena Therapeutics, Inc. plans to initiate a Phase 1
clinical trial for its T-cell-engager AMV564, a molecule developed
from Affimed's TandAb platform, in patients with acute myeloid
leukemia (AML). AMV564 is a bispecific TandAb targeting CD33 on
tumor cells and CD3 on T-cells. Together with the existing investor
consortium, Affimed is financially supporting clinical development
of AMV564 with up to €1.5 million in a Series A extension financing
of Amphivena, €1.0 of which was invested in September 2016.
- MHC-peptides are a class of potentially highly specific tumor
antigens, but so far, generation of antibodies against these
peptides has been reported to be extremely challenging. Affimed has
successfully generated a number of T-cell TandAbs specifically
binding MHC-peptide complexes. Early preclinical evaluation of one
of these molecules has demonstrated potent in vitro killing only
for tumor cells endogenously expressing the targeted MHC-peptide
complex, control cell lines were not lysed. Affimed continues to
explore these MHC-peptide-specific TandAbs, which have the
potential to mediate selective and dose-dependent lysis of
MHC-target-positive cells.
Financial Highlights(Figures for the third quarter and
nine months of 2016 and 2015 represent unaudited figures)
Cash and cash equivalents and financial assets
totaled €49.1 million as of September 30, 2016 compared to €76.7
million as of December 31, 2015. The decrease was primarily
attributable to Affimed's operational expenses.
Net cash used in operating activities was €25.5
million for the nine months ended September 30, 2016 compared to
€14.5 million for the nine months ended September 30, 2015. The
increase was primarily related to higher cash expenditure for
research and development (R&D) in connection with our
development and collaboration programs.
Revenue for the third quarter of 2016 was €0.9
million compared to €1.2 million for the third quarter of 2015.
Revenue in both periods was derived from Affimed's collaborations
with Amphivena and AbCheck Service Revenue.
R&D expenses for the third quarter of 2016
were €8.8 million compared to €6.4 million for the third quarter of
2015. The increase was primarily related to higher expenses for
AFM11, preclinical programs and infrastructure. G&A expenses
for the third quarter of 2016 were nearly unchanged with €2.2
million compared to €2.1 million for the third quarter of 2015.
Net loss for the third quarter of 2016 was €10.3
million, or €0.31 per common share, compared to a net loss of €7.3
million, or €0.24 per common share, for the third quarter of 2015.
The increase in net loss was primarily related to increased
spending on R&D for AFM11, preclinical programs and
infrastructure. In addition, the result was affected by lower
revenue and lower other income.
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. Please refer to Affmed's
SEC filings for the notes that accompany its financial statements
and should be read in conjunction therewith.
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 "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 September 30 |
For the nine months ended September 30 |
| |
|
|
|
|
|
| |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
| |
|
|
|
|
|
| Revenue |
|
|
1,155 |
|
|
938 |
|
|
5,903 |
|
|
4,943 |
|
| |
|
|
|
|
|
| Other income -
net |
|
|
298 |
|
|
19 |
|
|
631 |
|
|
143 |
|
| Research and
development expenses |
|
|
(6,448 |
) |
|
(8,760 |
) |
|
(14,974 |
) |
|
(24,456 |
) |
| General and
administrative expenses |
|
|
(2,068 |
) |
|
(2,181 |
) |
|
(5,592 |
) |
|
(6,239 |
) |
| |
|
|
|
|
|
| Operating loss |
|
|
(7,063 |
) |
|
(9,984 |
) |
|
(14,032 |
) |
|
(25,609 |
) |
| |
|
|
|
|
|
| Finance income /
(costs) - net |
|
|
(193 |
) |
|
(311 |
) |
|
108 |
|
|
(1,183 |
) |
| |
|
|
|
|
|
| Loss before
tax |
|
|
(7,256 |
) |
|
(10,295 |
) |
|
(13,924 |
) |
|
(26,792 |
) |
| |
|
|
|
|
|
| Income taxes |
|
|
(36 |
) |
|
0 |
|
|
(36 |
) |
|
(2 |
) |
| |
|
|
|
|
|
| Loss for the
period |
|
|
(7,292 |
) |
|
(10,295 |
) |
|
(13,960 |
) |
|
(26,794 |
) |
| |
|
|
|
|
|
| Total comprehensive
loss |
|
|
(7,292 |
) |
|
(10,295 |
) |
|
(13,960 |
) |
|
(26,794 |
) |
| |
|
|
|
|
|
| Loss per share in € per
share (undiluted = diluted) |
|
|
(0.24 |
) |
|
(0.31 |
) |
|
(0.52 |
) |
|
(0.81 |
) |
Affimed N.V.Condensed consolidated
statement of financial position (in € thousand)
|
|
December 31, 2015 |
|
September 30, 2016 |
| |
|
|
(unaudited) |
| ASSETS |
|
|
|
| Non-current
assets |
|
|
|
| |
|
|
|
| Intangible assets |
|
72 |
|
|
|
64 |
|
| Leasehold improvements
and equipment |
|
915 |
|
|
|
845 |
|
| |
|
987 |
|
|
|
909 |
|
| Current
assets |
|
|
|
| |
|
|
|
| Inventories |
|
228 |
|
|
|
253 |
|
| Trade and other
receivables |
|
915 |
|
|
|
2,337 |
|
| Other assets |
|
452 |
|
|
|
603 |
|
| Financial assets |
|
0 |
|
|
|
13,440 |
|
| Cash and cash
equivalents |
|
76,740 |
|
|
|
35,693 |
|
| |
|
78,335 |
|
|
|
52,326 |
|
| |
|
|
|
| TOTAL
ASSETS |
|
79,322 |
|
|
|
53,235 |
|
| |
|
|
|
| EQUITY AND
LIABILITIES |
|
|
|
| Equity |
|
|
|
| |
|
|
|
| Issued capital |
|
333 |
|
|
|
333 |
|
| Capital reserves |
|
187,169 |
|
|
|
189,888 |
|
| Accumulated
deficit |
|
(120,228 |
) |
|
|
(147,022 |
) |
| Total
equity |
|
67,274 |
|
|
|
43,199 |
|
| |
|
|
|
| Non-current
liabilities |
|
|
|
| |
|
|
|
| Borrowings |
|
3,104 |
|
|
|
1,685 |
|
| Total
non-current liabilities |
|
3,104 |
|
|
|
1,685 |
|
| |
|
|
|
| Current
liabilities |
|
|
|
| |
|
|
|
| Trade and other
payables |
|
4,444 |
|
|
|
6,327 |
|
| Borrowings |
|
1,472 |
|
|
|
1,959 |
|
| Deferred revenue |
|
3,028 |
|
|
|
65 |
|
| Total current
liabilities |
|
8,944 |
|
|
|
8,351 |
|
| |
|
|
|
| TOTAL EQUITY AND
LIABILITIES |
|
79,322 |
|
|
|
53,235 |
|
Affimed N.V.Unaudited condensed
consolidated statement of cash flows (in € thousand)
|
|
For the nine months ended September 30 |
|
|
|
2015 |
|
|
|
2016 |
|
|
Cash flow from operating activities |
|
|
|
|
Loss for the period |
|
(13,960 |
) |
|
|
(26,794 |
) |
|
Adjustments for the period: |
|
|
|
| -
Income taxes |
|
36 |
|
|
|
2 |
|
| -
Depreciation and amortization |
|
240 |
|
|
|
293 |
|
| -
Share based payments |
|
1,453 |
|
|
|
2,719 |
|
| -
Finance income / costs - net |
|
(108 |
) |
|
|
1,183 |
|
|
|
|
(12,339 |
) |
|
|
(22,597 |
) |
|
Change in trade and other receivables |
|
(508 |
) |
|
|
(1,398 |
) |
|
Change in inventories |
|
(40 |
) |
|
|
(25 |
) |
|
Change in other assets |
|
0 |
|
|
|
(151 |
) |
|
Change in trade, other payables and deferred revenue |
|
(1,218 |
) |
|
|
(1,080 |
) |
|
Cash used in operating activities |
|
(14,105 |
) |
|
|
(25,251 |
) |
|
Interest received |
|
5 |
|
|
|
60 |
|
|
Paid interest |
|
(426 |
) |
|
|
(355 |
) |
|
Net cash used in operating activities |
|
(14,526 |
) |
|
|
(25,546 |
) |
|
|
|
|
|
|
Cash flow from investing activities |
|
|
|
|
Purchase of intangible assets |
|
(10 |
) |
|
|
(21 |
) |
|
Purchase of leasehold improvements and equipment |
|
(204 |
) |
|
|
(194 |
) |
|
Cash paid for investments in financial assets |
|
0 |
|
|
|
(27,088 |
) |
|
Cash received from maturity of financial assets |
|
0 |
|
|
|
13,536 |
|
|
Net cash used for investing activities |
|
(214 |
) |
|
|
(13,767 |
) |
|
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
Proceeds from issue of common shares |
|
37,524 |
|
|
|
0 |
|
|
Transactions costs related to issue of common shares |
|
(3,090 |
) |
|
|
0 |
|
|
Repayment of borrowings |
|
0 |
|
|
|
(1,079 |
) |
|
Cash flow from financing activities |
|
34,434 |
|
|
|
(1,079 |
) |
|
|
|
|
|
|
Net changes to cash and cash equivalents |
|
19,694 |
|
|
|
(40,392 |
) |
|
Cash and cash equivalents at the beginning of the
period |
|
39,725 |
|
|
|
76,740 |
|
|
Exchange-rate related changes of cash and cash
equivalents |
|
1,006 |
|
|
|
(655 |
) |
|
Cash and cash equivalents at the end of the period* |
|
60,425 |
|
|
|
35,693 |
|
|
|
|
|
|
|
*Total cash and cash equivalents and financial assets as of
September 30, 2016: 49,133 (September 30, 2015: 60,425) |
Affimed N.V.Unaudited condensed
consolidated statement 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 |
57 |
|
33,433 |
|
|
|
|
33,490 |
|
| Exercise of share based
payment awards |
2 |
|
942 |
|
|
|
|
944 |
|
| Equity-settled share
based payment awards |
|
|
1,453 |
|
|
|
|
1,453 |
|
| Loss for the
period |
|
|
|
|
|
(13,960 |
) |
|
|
(13,960 |
) |
| |
|
|
|
|
|
|
|
| Balance as of
September 30, 2015 |
299 |
|
167,372 |
|
|
(113,949 |
) |
|
|
53,722 |
|
| |
|
|
|
|
|
|
|
| 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 |
|
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