- Company to focus on the development of AFM13,
AFM24 and preclinical innate cell engagers, decides to terminate
AFM11 T cell engager Phase 1 program -
- Received milestone payment from Genentech,
continuing to strengthen cash position from non-dilutive sources
-
- Clinical study updates of AFM13 as monotherapy
and in combination with Keytruda® (pembrolizumab) will be
highlighted in oral and poster presentations at the 15th
International Conference on Malignant Lymphoma (ICML) -
Heidelberg, Germany, May 22, 2019 - Affimed N.V.
(Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced a plan to focus its research and
development investments on advancing on-going and previously
announced clinical trials for its innate cell engager candidates,
AFM13 and AFM24. As part of the strategic plan, Affimed will
terminate the Phase 1 clinical program of AFM11, a
CD19/CD3-targeting bispecific T cell engager. The Company also
provided an update on recent operational progress and reported
financial results for the quarter ended March 31, 2019.
“We are focused on advancing our CD16A-targeting
innate cell engager product candidates as we progress through 2019,
with the goals of initiating a market registration-directed study
of AFM13 and entering the clinic with AFM24,” said Dr. Adi Hoess,
Affimed’s CEO. “We strongly believe our innate cell engagers could
enhance current immuno-oncology approaches and address unmet
patient needs in treating hematologic and solid tumor malignancies.
We have determined that the optimal use of our resources at this
time is to advance our innate cell engagers, focusing their
development on indications with high unmet need and the potential
for a rapid path to regulatory approval. In addition to advancing
our current clinical product candidates, we are working toward
expanding our early clinical stage pipeline and exploring rational
combinations of our innate cell engagers with other therapeutic
modalities such as adoptive NK cell therapies."
Corporate Updates
- Affimed received a milestone payment from Genentech, a member
of the Roche Group, triggered by the achievement of a preclinical
milestone under its research collaboration with Genentech to
develop and commercialize novel natural killer (NK) cell
engager-based immunotherapeutics based on Affimed’s ROCK® platform
to treat multiple cancers.
- Dr. Martin Treder has informed Affimed that he intends to step
down from his position as Chief Scientific Officer to pursue new
opportunities. Dr. Treder will continue as a consultant to the
Company.
Dr. Hoess commented, “Martin oversaw the
development of Affimed’s ROCK® platform. We thank Martin for his
many contributions to Affimed during his tenure as CSO, and wish
him success in his future endeavors.”
Pipeline Updates and Upcoming Clinical
Plans
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
- At the American Association for Cancer Research (AACR) Annual
Meeting 2019, Affimed together with its collaboration partners from
Washington University School of Medicine, St. Louis, MO, presented
data that describe functional responses of conventional and
cytokine-induced memory-like (CIML) NK cells in the presence or
absence of AFM13. In a poster titled, "The CD30/CD16A bispecific
innate immune cell engager AFM13 elicits heterogeneous single cell
NK cell responses and effectively triggers memory like (ML) NK
cells," preclinical data showed that AFM13 significantly enhanced
NK cell recognition of CD30-positive tumor cells and this enhanced
tumor recognition correlated with superior NK cell activation. In
the study, the combination of CIML NK cells with AFM13 potentiated
cytokine secretion and cytotoxicity towards tumor target cells,
further demonstrating the rationale for combining AFM13 with
adoptive NK cell-based therapies as a promising therapeutic
approach for treating CD30-positive malignancies.
- Abstracts providing updates on AFM13 clinical studies have been
accepted for oral and poster presentations at the 15th
International Conference on Malignant Lymphoma (ICML), to be held
from June 18-22, 2019, in Lugano, Switzerland. The oral
presentation includes updated data from the combination study of
AFM13 with Merck's Keytruda® (pembrolizumab) in patients with
relapsed or refractory Hodgkin lymphoma (HL). In addition, a poster
presentation will highlight data from the investigator-sponsored
study of AFM13 as monotherapy in patients with relapsed or
refractory CD30-positive lymphoma with cutaneous manifestations.
Details on these presentations are expected to be available in
mid-June through the ICML meeting website at www.lymphcon.ch.
- Affimed filed with U.S. Food and Drug Administration (FDA) the
full study protocol for the Company’s Phase 2 registration-directed
study of AFM13 as monotherapy in relapsed or refractory patients
with peripheral T cell lymphoma (PTCL) and transformed mycosis
fungoides, a subset of cutaneous T cell lymphoma. The study
commencement is targeted for the second half of 2019 pending
agreement with the FDA on the final study protocol.
- An investigator-sponsored study directed towards development of
an off-the-shelf adoptive immunotherapy comprised of AFM13
pre-mixed with expanded cord blood-derived allogeneic NK cells in
patients with relapsed/refractory CD30-positive malignancies is
planned by The University of Texas MD Anderson Cancer Center
(MDACC) with the support of Affimed.
AFM24 (EGFR/CD16A)
- At the AACR Annual Meeting 2019, a poster titled, "Preclinical
characterization of the bispecific EGFR/CD16A innate immune cell
engager AFM24 for the treatment of EGFR-expressing solid tumors,"
highlighted potentially differentiating features of AFM24 versus
standard of care anti-EGFR therapies, such as the monoclonal
antibody cetuximab. AFM24 demonstrated the ability to bridge NK
cells and macrophages to EGFR expressing tumor cell lines, and
induced lysis through antibody-dependent cellular cytotoxicity
(ADCC) and antibody-dependent cellular phagocytosis (ADCP),
respectively, which was independent of RAS mutational status. AFM24
enhanced tumor infiltration of NK cells and elicited dose-dependent
anti-tumor efficacy in in vivo tumor models. Importantly, AFM24
showed reduced inhibition of EGFR phosphorylation relative to the
standard of care, cetuximab. Treatment of cynomolgus monkeys with
AFM24 showed a favorable safety profile, even when treated at high
dose levels, demonstrating AFM24's potential to have significantly
lower toxicities in humans compared to standard of care.
- Affimed currently anticipates completing investigational new
drug (IND)-enabling studies of AFM24 by mid-year 2019 to support
the initiation of the first-in-human study of AFM24 in the second
half of 2019.
Financial Highlights
(Figures for the first quarter of 2019 and for
the first quarter 2018 are unaudited.)
Pro-forma cash, cash equivalents and short-term
deposits, including the milestone payment under the Genentech
collaboration that the Company received in April 2019, totaled
€100.4 million or approximately $113 million, as of March 31, 2019.
Cash, cash equivalents and short-term deposits on December 31, 2018
were €108.8 million. Based on its current operating and budget
assumptions, Affimed anticipates that its cash, cash equivalents
and short-term deposits as of March 31, 2019 will enable the
Company to fund its planned clinical development and early
development activities into 2021.
Net cash used in operating activities was €13.4
million for the three months ended March 31, 2019 compared to net
cash used in operating activities of €6.9 million for the three
months ended March 31, 2018.
Total revenue was €11.4 million for the three
months ended March 31, 2019 compared to €0.5 million for the three
months ended March 31, 2018. The increase in revenue is primarily
attributable to the recognition of €10.6 million as revenue from
the Genentech collaboration in the first quarter of 2019.
Research and development (R&D) expenses for
the first quarter of 2019 were €8.0 million compared to €6.4
million for the first quarter of 2018. The increase was primarily
related to higher expenses related to clinical study startup
activities for the AFM13 registration study in PTCL, as well as
early stage development and discovery activities.
General and administrative (G&A) expenses
for the first quarter of 2019 were higher at €2.4 million compared
to €2.0 million for the first quarter of 2018. This increase was
primarily related to higher personnel expenses.
Net income was €1.9 million, or €0.03 per common
share, for the first quarter of 2019, compared to a net loss of
€8.2 million, or €0.15 per common share, for the first quarter of
2018. Net income was primarily related to significantly increased
revenue, partially offset by higher R&D and G&A
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 Information
Affimed will host a conference call and webcast
today, Wednesday, May 22, 2019 at 8:30 a.m. Eastern time to discuss
the company’s financial results and recent corporate developments.
To access the call, please dial +1 (631) 510-7495 for U.S. callers,
or +44 (0) 2071 928000 for international callers, and reference
conference ID 1083705 approximately 15 minutes prior to the call.
An audio webcast of the conference call can be accessed in the
“Webcasts” section on the “Investors” page of the Affimed website
at https://www.affimed.com/investors/webcasts/. 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) is a clinical stage
biopharmaceutical company that engineers targeted immunotherapies,
seeking to improve patient outcomes through the power of innate
immunity. Affimed’s fit-for-purpose ROCK® platform allows innate
immune engagers to be designed for specific patient populations.
The Company is developing single and combination therapies to treat
cancers. 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, 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.Unaudited
consolidated statements of comprehensive income/(loss) (in €
thousand)
|
For the three months endedMarch
31 |
|
|
|
|
2019 |
|
2018 |
Revenue |
|
|
11,353 |
|
532 |
|
|
|
|
|
|
Other income – net |
|
|
86 |
|
(11) |
Research and development
expenses |
|
|
(7,987) |
|
(6,396) |
General and administrative
expenses |
|
|
(2,434) |
|
(2,038) |
|
|
|
|
|
|
Operating income /
(loss) |
|
|
1,018 |
|
(7,913) |
|
|
|
|
|
|
Finance income /
(costs) – net |
|
|
834 |
|
(289) |
|
|
|
|
|
|
Income / (loss) before
tax |
|
|
1,852 |
|
(8,202) |
|
|
|
|
|
|
Income taxes |
|
|
0 |
|
(1) |
|
|
|
|
|
|
Income / (loss) for
the period |
|
|
1,852 |
|
(8,203) |
|
|
|
|
|
|
Other comprehensive
income / (loss) |
|
|
|
|
|
Items that will not be
reclassified to profit or loss |
|
|
|
|
|
Equity investments at fair
value OCI - net change in fair value |
|
|
73 |
|
(195) |
|
|
|
|
|
|
Other comprehensive
income / (loss) |
|
|
73 |
|
(195) |
|
|
|
|
|
|
Total comprehensive
income / (loss) |
|
|
1,925 |
|
(8,398) |
|
|
|
|
|
|
Earnings / (loss) per
share in € per share(undiluted =
diluted) |
|
|
0.03 |
|
(0.15) |
|
|
|
|
|
|
Weighted number of
common shares outstanding |
|
|
62,430,106 |
|
54,838,038 |
Affimed N.V.Consolidated
statements of financial position (in € thousand)
|
March 31, 2019 |
|
December 31, 2018 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
107 |
|
56 |
Leasehold improvements and
equipment |
1,374 |
|
1,414 |
Long term financial
assets |
3,898 |
|
3,825 |
Right-of-use assets |
635 |
|
0 |
|
6,014 |
|
5,295 |
|
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
63,089 |
|
94,829 |
Financial assets |
32,043 |
|
13,974 |
Trade and other
receivables |
8,298 |
|
1,429 |
Inventories |
325 |
|
260 |
Other assets |
570 |
|
387 |
|
104,325 |
|
110,879 |
|
|
|
|
TOTAL
ASSETS |
110,339 |
|
116,174 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
624 |
|
624 |
Capital reserves |
239,656 |
|
239,055 |
Fair value reserves |
2,667 |
|
2,594 |
Accumulated deficit |
(200,292) |
|
(202,144) |
Total
equity |
42,655 |
|
40,129 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
957 |
|
1,690 |
Contract liabilities |
33,488 |
|
37,512 |
Lease liabilities |
302 |
|
0 |
Total non-current
liabilities |
34,747 |
|
39,202 |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
6,289 |
|
9,425 |
Borrowings |
3,083 |
|
3,083 |
Lease liabilities |
334 |
|
0 |
Contract
liabilities |
23,231 |
|
24,335 |
Total current
liabilities |
32,937 |
|
36,843 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
110,339 |
|
116,174 |
Affimed N.V.Unaudited
consolidated statements of cash flows (in € thousand)
|
For the three months ended March
31 |
|
|
2019 |
|
2018 |
Cash flow
from operating activities |
|
|
|
|
Income / (loss)
for the period |
|
1,852 |
|
(8,203) |
Adjustments for
the period: |
|
|
|
|
- Income
taxes |
|
0 |
|
1 |
- Depreciation and
amortisation |
|
210 |
|
99 |
- Net gain from
disposal of leasehold improvements and equipment |
|
(9) |
|
0 |
- Share based
payments |
|
601 |
|
370 |
- Finance income /
costs – net |
|
(834) |
|
289 |
|
|
1,820 |
|
(7,444) |
Change in trade
and other receivables |
|
(6,688) |
|
(711) |
Change in
inventories |
|
(65) |
|
(21) |
Change in other
assets |
|
(183) |
|
(17) |
Change in trade,
other payables and contract liabilities |
|
(8,252) |
|
1,345 |
Cash used in
operating activities |
|
(13,368) |
|
(6,848) |
Interest
received |
|
62 |
|
26 |
Paid interest |
|
(77) |
|
(101) |
Net cash
used in operating activities |
|
(13,383) |
|
(6,923) |
|
|
|
|
|
Cash flow
from investing activities |
|
|
|
|
Purchase of
intangible assets |
|
(64) |
|
(9) |
Purchase of
leasehold improvements and equipment |
|
(66) |
|
(146) |
Cash received from
the sale of leasehold improvements and equipment |
|
0 |
|
1 |
Cash paid for
investments in financial assets |
|
(21.061) |
|
0 |
Cash received from
maturity of financial assets |
|
3,513 |
|
0 |
Net cash
used for investing activities |
|
(17,678) |
|
(154) |
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
Proceeds from
issue of common shares |
|
0 |
|
25,042 |
Transaction costs
related to issue of common shares |
|
0 |
|
(1,646) |
Repayment of lease
liabilities |
|
(82) |
|
0 |
Repayment of
borrowings |
|
(833) |
|
(750) |
Cash flow
from financing activities |
|
(915) |
|
22,646 |
|
|
|
|
|
Exchange-rate
related changes of cash and cash equivalents |
|
236 |
|
(66) |
Net
changes to cash and cash equivalents |
|
(31,976) |
|
15,568 |
Cash and
cash equivalents at the beginning of the period |
|
94,829 |
|
39,837 |
Cash and
cash equivalents at the end of the period |
|
63,089 |
|
55,339 |
Affimed N.V.Unaudited
consolidated statements of changes in equity (in €
thousand)
|
|
Issued capital |
|
Capital reserves |
|
Fair
value reserves |
|
Accumulated deficit |
|
Total equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as
of January 1, 2018 |
|
468 |
|
213,778 |
|
7,325 |
|
(182,667) |
|
38,904 |
Issue of common
shares |
|
156 |
|
23,230 |
|
|
|
|
|
23,386 |
Equity-settled
share based payment awards |
|
|
|
370 |
|
|
|
|
|
370 |
Loss for the
period |
|
|
|
|
|
|
|
(8,203) |
|
(8,203) |
Other
comprehensive income |
|
|
|
|
|
(195) |
|
|
|
(195) |
|
|
|
|
|
|
|
|
|
|
|
Balance as
of March 31, 2018 |
|
624 |
|
237,378 |
|
7,130 |
|
(190,870) |
|
54,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as
of January 1, 2019 |
|
624 |
|
239,055 |
|
2,594 |
|
(202.144) |
|
40,129 |
Equity-settled
share based payment awards |
|
|
|
601 |
|
|
|
|
|
601 |
Income for the
period |
|
|
|
|
|
|
|
1,852 |
|
1,852 |
Other
comprehensive income |
|
|
|
|
|
73 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
Balance as
of March 31, 2019 |
|
624 |
|
239,656 |
|
2,667 |
|
(200,292) |
|
42,655 |
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