Heidelberg, Germany, August 7, 2019 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today reported financial and operating results for the
second quarter ended June 30, 2019.
“After reaching agreement with the U.S. Food and
Drug Administration on the study protocol design, we are now in the
process of preparing to initiate the AFM13 registration-directed
Phase 2 study,” said Dr. Adi Hoess, Affimed’s CEO. “The recent
positive final and interim results from two clinical studies of
AFM13 add to the growing body of evidence supporting AFM13’s
activity in CD30-positive lymphoma patients, and give us increased
confidence in the potential of AFM13 to demonstrate clinical
benefit in CD30-positive peripheral T cell lymphoma. To execute the
Phase 2 study and to further advance our internal and partnered
CD16A-targeting innate cell engager pipeline, we have significantly
strengthened our organization through the addition of multiple key
hires in the U.S. and Germany of individuals who have substantial
drug development experience.”
Corporate Updates
- Affimed strengthened its drug development team with the
addition of experienced personnel in several key areas, including
Regulatory Affairs, Clinical Development and Operations, Drug
Safety, Chemistry, Manufacturing and Control (CMC), Drug Safety
& Pharmacovigilance, Biostatistics and Commercial Strategy. The
new hires previously held positions at Novartis, Pfizer Inc.,
Abbott, Eli Lilly and Company and other large pharmaceutical or
biotechnology companies.
- In April, Affimed received a payment from Genentech triggered
by the achievement of a preclinical milestone under its research
collaboration to develop and commercialize novel natural killer
(NK) cell engager-based immunotherapeutics based on Affimed’s ROCK®
platform to treat multiple cancers.
- Affimed was added to the Russell 2000®, Russell 3000®, and
Russell Microcap® Indexes, effective after the U.S. markets closed
on Friday, June 28, 2019 as part of Russell’s annual index
rebalance process. Russell U.S. Indexes are widely used by
investment managers and institutional investors as the basis for
index funds and as benchmarks for active investment
strategies.
- In June 2019, Affimed’s subsidiary AbCheck entered into a
five-year licensing agreement with Icosagen granting AbCheck access
to Icosagen’s QMCF protein production technology. Under the terms
of the agreement, AbCheck acquires the rights to utilize Icosagen’s
QMCF technology platform for its commercial activities in antibody
discovery.
Pipeline Updates
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
- Affimed reached agreement with the U.S. Food and Drug
Administration regarding the design of its planned Phase 2
registration-directed study of AFM13 as monotherapy in relapsed or
refractory patients with CD30-positive peripheral T cell lymphoma
(PTCL). The results, if positive, could form the basis for a
Biologics License Application (BLA) submission and support an
accelerated approval given the unmet medical need for safe and
effective new treatments in this hard-to-treat patient population.
The study will also enroll a cohort of patients with transformed
mycosis fungoides, an aggressive subtype of cutaneous T cell
lymphoma. Study start-up activities are under way, with study
commencement anticipated in the second half of 2019.
- Updated data from 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 was presented at the International Conference on
Malignant Lymphomas (ICML) in Lugano in June 2019. The data
confirmed single-agent activity of AFM13 in CD30-positive lymphoma
patients, with an objective response rate (ORR) of 50% (5 out of 10
patients). Tumor biopsies showed increased infiltration of NK cells
in responders compared to non-responders, and evidence of NK
cell-mediated killing.
- Affimed reported the final results from the Phase 1b dose
escalation study of AFM13 plus pembrolizumab that showed
encouraging efficacy in the intent-to-treat (ITT) patient
population (n=30) with an ORR of 83%, including complete responses
(CR) in 40% and partial responses (PR) in 43% of patients with
hard-to-treat Hodgkin lymphoma. At the highest treated dose (n=24),
patients showed an ORR of 88% (CR of 46% and PR of 42%) as
determined by independent assessment. Overall, the combination of
AFM13 and pembrolizumab showed a favorable safety profile in
patients, including some patients who did not respond to first-line
chemotherapy and a subgroup of patients who were primary refractory
to brentuximab vedotin. Importantly, a deepening of responses was
reported over time in multiple patients. In addition, patients
previously transplant-ineligible transitioned to transplant after
achieving an objective response with the combination of AFM13 and
pembrolizumab, thus increasing the chance for a cure. These
positive results, taken together with data demonstrating
single-agent activity of AFM13 in CD30-positive T cell lymphoma
patients, form the basis for Affimed to initiate a
registration-directed study of AFM13 as monotherapy in patients
with PTCL.
- The combination of AFM13 with allogeneic NK cells represents a
novel approach in order to further improve response rates and
durability of responses in patients with relapsed/refractory
CD30-positive lymphoma. In a preclinical collaboration with the
University of Texas MD Anderson Cancer Center (MDACC), AFM13 has
been shown to bind to CD16A with much higher affinity than other
CD16A binding moieties such as monoclonal antibodies, thus enabling
the formation of a stable complex of AFM13 pre-mixed with cord
blood-derived allogeneic NK cells. This stable complex showed
strong efficacy in in vitro and in vivo experiments, forming the
basis for an investigator-sponsored Phase 1 study by MDACC. In the
study, MDACC intends to administer this stable complex in different
doses (numbers of pre-loaded NK cells) into patients with
relapsed/refractory CD30-positive malignancies.
AFM24 (EGFR/CD16A)
- AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding
innate cell engager from Affimed’s ROCK® platform. It is designed
to target EGFR-expressing solid tumors by a new mechanism of action
that activates innate immunity. This is a differentiated approach
from cetuximab and other EGFR targeting approaches that inhibit
tumor growth by EGFR-mediated signal transduction. Affimed
presented data at the American Association for Cancer Research
(AACR) 2019 Annual Meeting that demonstrated AFM24’s ability to
bridge NK cells and macrophages to EGFR expressing tumor cell lines
and induce lysis through antibody-dependent cellular cytotoxicity
(ADCC) and antibody-dependent cellular phagocytosis (ADCP),
respectively. Due to AFM24’s different mode of action these
effects were independent of RAS mutational status. Importantly,
AFM24 enhanced tumor infiltration of NK cells and elicited
dose-dependent anti-tumor efficacy in in vivo tumor models. AFM24
showed reduced inhibition of EGFR phosphorylation relative to the
monoclonal antibody cetuximab. Treatment of cynomolgus monkeys with
AFM24 resulted in 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 submitting the investigational
new drug (IND) application for AFM24 around the end of the third
quarter 2019.
Technology Updates
- Data describing Affimed’s ROCK® antibody platform was published
in the mAbs journal, titled, “Redirected optimized cell killing
(ROCK®): A highly versatile multispecific fit-for-purpose antibody
platform for engaging innate immunity.” The paper discusses aspects
of the modular platform, including the advantages of innate immune
cell engagement over monoclonal antibodies and other engager
concepts. The article also describes the potential of the ROCK®
platform to engineer a fit-for-purpose innate immune cell engager
format that can be equipped with unique CD16A domains, modules that
influence pharmacokinetic properties and molecular architectures
that influence the activation of immune effectors, as well as tumor
targeting. The article is available at:
https://doi.org/10.1080/19420862.2019.1616506.
Financial Highlights
(Figures for the second quarter and six months
ended June 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial
assets totaled €87.7 million as of June 30, 2019, compared to
€108.8 million as of December 31, 2018. Based on its current
operating and budget assumptions, Affimed anticipates that its
cash, cash equivalents and current financial assets as of June 30,
2019 will enable the Company to fund its planned clinical
development and early development activities into 2021.
Net cash used in operating activities was €18.9
million for the six months ended June 30, 2019, compared to net
cash used in operating activities of €15.2 million for the six
months ended June 30, 2018. The increase is primarily due to higher
cash expenditure for research and development efforts.
Total revenue was €4.0 million for the three
months ended June 30, 2019 compared to €0.2 million for the three
months ended June 30, 2018. The increase in revenue is attributable
to the recognition of €3.7 million as revenue from the Genentech
collaboration in the second quarter of 2019.
Research and development (R&D) expenses for
the second quarter of 2019 were €11.5 million, including accrued
termination costs of €1.4 million associated with the wind-down
activities for the two Phase 1 studies of AFM11. R&D expenses
for the second quarter of 2018 were €7.1 million. The increase was
primarily related to higher expenses related to manufacturing
activities for clinical study material for AFM13, startup
activities for the AFM13 registration study in PTCL, early stage
development and discovery activities, and the termination costs for
the two AFM11 clinical studies.
General and administrative (G&A) expenses
for the second quarter of 2019 were nearly unchanged at €2.3
million compared to €2.2 million for the second quarter of
2018.
Net loss was €10.3 million, or €0.17 per common
share, for the second quarter of 2019, compared to a net loss of
€8.0 million, or €0.13 per common share, for the second quarter of
2018.
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, August 7, 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 (917) 720-0178 for
U.S. callers, or +44 (0) 203 0095710 for international callers, and
reference conference ID 9396039 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 committed to giving patients back their
innate ability to fight cancer. Affimed’s fit-for-purpose ROCK®
platform allows innate cell engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat hematologic and solid tumors. 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 monthsended June
30 |
|
For the six monthsended June
30 |
|
|
|
|
|
|
|
|
|
|
2019 |
|
2018 |
2019 2018 |
|
|
|
|
|
|
|
|
Revenue |
|
4,008 |
|
150 |
15,361 |
682 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income – net |
|
197 |
|
49 |
283 |
38 |
|
|
|
|
|
|
|
Research and development expenses |
|
(11,545) |
|
(7,149) |
(19,532) |
(13,545) |
|
|
|
|
|
|
|
General and administrative expenses |
|
(2,342) |
|
(2,164) |
(4,776) |
(4,202) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income / (loss) |
|
(9,682) |
|
(9,114) |
(8,664) |
(17,027) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income / (costs) – net |
|
(654) |
|
1,100 |
180 |
811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income / (loss) before tax |
|
(10.336) |
|
(8,014) |
(8,484) |
(16,216) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
(4) |
|
0 |
(4) |
(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income / (loss) for the period |
|
(10,340) |
|
(8,014) |
(8,488) |
(16,217) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income / (loss) Items
that will not be reclassified to profit or lossEquity
investments at fair valueOCI – net change in fair value |
|
(49) |
|
406 |
24 |
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income / (loss) |
|
(49) |
|
406 |
24 |
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income / (loss) |
|
(10,389) |
|
(7,608) |
(8,464) |
(16,006) |
|
|
|
|
|
|
|
Earnings / (loss) per share in € per share |
|
(0.17) |
|
(0.13) |
(0.14) |
(0.28) |
|
|
|
|
|
|
|
(undiluted = diluted) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted number of common shares outstanding |
|
62,439,363 |
62,390,068 62,434,734 |
58,614,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affimed N.V.Consolidated
statements of financial position (in € thousand)
|
June 30, 2019 |
|
December 31, 2018 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current assets |
|
|
|
Intangible
assets |
168 |
|
56 |
Leasehold
improvements and equipment |
1,960 |
|
1,414 |
Long term
financial assets |
3,849 |
|
3,825 |
Right-of-use
assets |
653 |
|
0 |
|
6,630 |
|
5,295 |
Current assets |
|
|
|
Cash and cash
equivalents |
63,987 |
|
94,829 |
Financial
assets |
23,726 |
|
13,974 |
Trade and
other receivables |
1,471 |
|
1,429 |
Inventories |
330 |
|
260 |
Other
assets |
2,973 |
|
387 |
|
92,487 |
|
110,879 |
TOTAL
ASSETS |
99,117 |
|
116,174 |
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
Equity |
|
|
|
Issued
capital |
624 |
|
624 |
Capital
reserves |
240,235 |
|
239,055 |
Fair value
reserves |
2,618 |
|
2,594 |
Accumulated
deficit |
(210,632) |
|
(202,144) |
Total
equity |
32,845 |
|
40,129 |
|
|
|
|
Non-current liabilities |
|
|
|
Borrowings |
323 |
|
1,690 |
Contract
liabilities |
39,138 |
|
37,512 |
Lease
liabilities |
246 |
|
0 |
Total
non-current liabilities |
39,707 |
|
39,202 |
|
|
|
|
Current liabilities |
|
|
|
Trade and
other payables |
7,541 |
|
9,425 |
Provisions |
1,440 |
|
0 |
Borrowings |
3,552 |
|
3,083 |
Lease
liabilities |
377 |
|
0 |
Contract
liabilities |
13,655 |
|
24,335 |
Total
current liabilities |
26,565 |
|
36,843 |
|
|
|
|
TOTAL
EQUITY AND LIABILITIES |
99,117 |
|
116,174 |
|
|
|
|
|
Affimed N.V.Unaudited
consolidated statements of cash flows (in € thousand)
|
|
For the six months endedJune
30 |
|
|
2019 |
|
2018 |
|
Cash flow from operating activities |
|
|
|
|
Income
/ (loss) for the period |
(8,488) |
|
(16,217) |
|
Adjustments for the period: |
|
|
|
|
-
Income taxes |
4 |
|
1 |
|
-
Depreciation and amortisation |
423 |
|
199 |
|
- Net
gain from disposal of leasehold improvements and equipment |
(9) |
|
0 |
|
-
Share based payments |
1,167 |
|
937 |
|
-
Finance income / costs – net |
(180) |
|
(811) |
|
|
(7,083) |
|
(15,891) |
|
Change
in trade and other receivables |
228 |
|
88 |
|
Change
in inventories |
(70) |
|
(26) |
|
Change
in other assets |
(2,586) |
|
(1,159) |
|
Change
in trade, other payables, provisions and contract liabilities |
(9,484) |
|
1,970 |
|
Cash
used in operating activities |
(18,995) |
|
(15,018) |
|
Interest received |
188 |
|
58 |
|
Paid
interest |
(134) |
|
(196) |
|
Net cash used in operating activities |
(18,941) |
|
(15,156) |
|
|
|
|
|
|
Cash flow from investing activities |
|
|
|
|
Purchase of intangible assets |
(142) |
|
(26) |
|
Purchase of leasehold improvements and equipment |
(755) |
|
(298) |
|
Cash
received from the sale of leasehold improvements and equipment |
0 |
|
1 |
|
Cash
paid for investments in financial assets |
(35,262) |
|
0 |
|
Cash
received from maturity of financial assets |
25,748 |
|
0 |
|
Net cash used for investing activities |
(10,411) |
|
(323) |
|
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
Proceeds from issue of common shares |
13 |
|
25,042 |
|
Transaction costs related to issue of common shares |
0 |
|
(1,686) |
|
Proceeds from borrowings |
562 |
|
0 |
|
Repayment of lease liabilities |
(206) |
|
0 |
|
Repayment of borrowings |
(1,649) |
|
(1,500) |
|
Cash flow from financing activities |
(1,280) |
|
21,856 |
|
Exchange-rate related changes of cash and cash
equivalents |
(210) |
|
1,198 |
|
Net changes to cash and cash equivalents |
(30,632) |
|
6,377 |
|
Cash and cash equivalents at the beginning of the
period |
94,829 |
|
39,837 |
|
Cash and cash equivalents at the end of the
period |
63,987 |
|
47,412 |
|
|
|
|
|
|
|
|
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 |
|
23,190 |
|
|
|
|
|
23,346 |
Equity-settled
share based payment awards |
|
|
937 |
|
|
|
|
|
937 |
Loss for the
period |
|
|
|
|
|
|
(16,217) |
|
(16,217) |
Other
comprehensive income |
|
|
|
|
211 |
|
|
|
211 |
Balance as of June 30, 2018 |
624 |
|
237,905 |
|
7,536 |
|
(198,884) |
|
47,181 |
Balance as of January 1,
2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Exercise of
share based payment awards |
|
|
13 |
|
|
|
|
|
13 |
Equity-settled
share based payment awards |
|
|
1,167 |
|
|
|
|
|
1,167 |
Loss for the
period |
|
|
|
|
|
|
(8,488) |
|
(8,488) |
Other
comprehensive income |
|
|
|
|
24 |
|
|
|
24 |
Balance as of June 30, 2019 |
624 |
|
240,235 |
|
2,618 |
|
(210,632) |
|
32,845 |
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